What you will do In this vital role you will strengthen and advance Amgen's R&D Quality Management System (QMS) and Safety & Medical Quality (SMQ) competencies. This role will lead Safety and Medical Quality processes with a focus on labelling and regulatory affairs activities. This role will be responsible for leading processes and activities related to the pharmacovigilance (GPvP) annual audit plan, the preparation and execution of audits, the investigation and monitoring of Quality events and supporting partner audits and regulatory inspections. The Quality Lead role in the Safety & Medical Quality organization will lead proactive identification of compliance issues relating to processes and programs, and escalation to compliance and quality oversight bodies, and participate in quality investigations, management, and remediation. Act as the Quality Lead contact for Labelling & Regulatory Affairs activities within R&D Quality. Ensure proactive identification of issues relating to processes, programs, and external relationships, elevate issues to appropriate compliance/quality oversight bodies and participate in compliance investigations, management, and remediation. Assess and manage risks including providing input into the development of the annual GPvP audit plan. Participate as the Quality representative for evaluating and providing oversight of Labelling and Regulatory Affairs vendors/service providers. Prepare, analyze, and communicate compliance metrics (e.g., deviation, audit and inspection data) and other significant compliance information. Represent R&D Quality during governance and management review meetings that involve Labelling and Regulatory Affairs. Maintain knowledge of current regulatory and compliance practices/issues, assess changes in regulations and the external environment, and advise customers. Support inspections and external audits, including preparing, conducting, and closing out response reviews. Provide support for audit planning meetings, debriefs, audit plan outlines and response reviews. Develop long-term remediations and process improvements through Root Cause Analysis (RCA). Improve R&D processes by contributing expertise in identifying robust Corrective and Preventive Action plans (CAPA) and Effectiveness Verifications. Actively seek and implement innovative and proactive quality oversight methodologies. What we expect of you Degree educated Experience in Quality Management, Quality Compliance or other relevant risk based quality practices in the pharmaceutical/biotech industry and thorough knowledge of R&D processes and operations Thorough knowledge and application of international requirements of Good Pharmacovigilance Practice (GPvP) & Regulatory Affairs Previous experience supporting regulatory authority inspections of pharmacovigilance activities Experience of leading and/or supporting process improvement initiatives Previous leadership or mentoring experience is ideal What you can expect of us Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits Location Ability to work flexibly from home with occasional office work from our Cambridge or Uxbridge next generation workspaces. Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
May 08, 2026
Full time
What you will do In this vital role you will strengthen and advance Amgen's R&D Quality Management System (QMS) and Safety & Medical Quality (SMQ) competencies. This role will lead Safety and Medical Quality processes with a focus on labelling and regulatory affairs activities. This role will be responsible for leading processes and activities related to the pharmacovigilance (GPvP) annual audit plan, the preparation and execution of audits, the investigation and monitoring of Quality events and supporting partner audits and regulatory inspections. The Quality Lead role in the Safety & Medical Quality organization will lead proactive identification of compliance issues relating to processes and programs, and escalation to compliance and quality oversight bodies, and participate in quality investigations, management, and remediation. Act as the Quality Lead contact for Labelling & Regulatory Affairs activities within R&D Quality. Ensure proactive identification of issues relating to processes, programs, and external relationships, elevate issues to appropriate compliance/quality oversight bodies and participate in compliance investigations, management, and remediation. Assess and manage risks including providing input into the development of the annual GPvP audit plan. Participate as the Quality representative for evaluating and providing oversight of Labelling and Regulatory Affairs vendors/service providers. Prepare, analyze, and communicate compliance metrics (e.g., deviation, audit and inspection data) and other significant compliance information. Represent R&D Quality during governance and management review meetings that involve Labelling and Regulatory Affairs. Maintain knowledge of current regulatory and compliance practices/issues, assess changes in regulations and the external environment, and advise customers. Support inspections and external audits, including preparing, conducting, and closing out response reviews. Provide support for audit planning meetings, debriefs, audit plan outlines and response reviews. Develop long-term remediations and process improvements through Root Cause Analysis (RCA). Improve R&D processes by contributing expertise in identifying robust Corrective and Preventive Action plans (CAPA) and Effectiveness Verifications. Actively seek and implement innovative and proactive quality oversight methodologies. What we expect of you Degree educated Experience in Quality Management, Quality Compliance or other relevant risk based quality practices in the pharmaceutical/biotech industry and thorough knowledge of R&D processes and operations Thorough knowledge and application of international requirements of Good Pharmacovigilance Practice (GPvP) & Regulatory Affairs Previous experience supporting regulatory authority inspections of pharmacovigilance activities Experience of leading and/or supporting process improvement initiatives Previous leadership or mentoring experience is ideal What you can expect of us Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits Location Ability to work flexibly from home with occasional office work from our Cambridge or Uxbridge next generation workspaces. Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Lead Regulatory Affairs Manager, International page is loaded Lead Regulatory Affairs Manager, Internationallocations: DE - Cologne: UK - London: Sweden: IT - Milantime type: Full timeposted on: Posted Todayjob requisition id: R26-12786 Help us change lives At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others. Position Overview The Lead Regulatory Affairs Manager, International will support or lead the creation and submission of product Technical Files/Standard Technical Documentation and other submission related documents for market authorizations in targeted markets and countries. The Lead Regulatory Affairs Manager, International supports or leads the creation and execution of regulatory strategy for assigned projects, including new product development, product changes, and manufacturing improvement initiatives. This role assists in creating, developing, and implementing global regulatory affairs procedures and educating others on global regulatory expectations and requirements. Essential Duties Include but are not limited to the following: Participate, lead or support the preparation and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution approvals and/or clearances. Support or lead as needed regulatory strategy development, document appropriate regulatory strategy for proposed new products and markets and initiate necessary activities by working with project teams and regulatory team members as needed. Control and maintain regulatory records. Represent Regulatory Affairs on project teams by attending team meetings and providing the required plans, procedures and regulatory decisions. Manage distributors and RA consultants to ensure global registrations are completed on time and maintained. Review and approve documents and product changes for regulatory compliance, determining if a new premarket application is required. Review technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry. Review and approve product labeling and marketing material. Provide Regulatory reviews and approvals of advertising, promotional and external product training materials in compliance with applicable regulatory and trade requirements and Exact Sciences Medical, Legal and Regulatory (MLR) review process. Demonstrate continuous pursuit of global regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including IVDR, UK CA, FDA and Health Canada regulations and policies applying to In Vitro Diagnostic medical devices including, PMAs, 510(k)s, labeling and promotional materials, global registration, and technical writing. Experience with regulators in the Middles East and/or Latin America will be a plus. Strong technical writing skills. Effective communicator: ability to convey messages in a logical and concise manner. Consistently reinforce regulatory expectations and requirements. Exceptional attention to detail. Strong organizational skills. Independent self-starter; manage time effectively and complete tasks on-time with minimal supervision. Flexible and able to self-manage multiple priorities. Ability to work effectively in multinational/multicultural environments. Adapt readily to changes in workload, staffing, and scheduling. Comply with management direction. Seek assistance from supervisor in identifying and reporting problems or concerns relating to job functions. Conduct self in a professional manner with coworkers, management, customers, and others. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company's Quality Management System policies and procedures. Regular and reliable attendance. Ability to work designated schedule. Ability to work nights and/or weekends as needed. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 75% of a typical working day. Ability to work on a computer and phone simultaneously. Ability to use a telephone through a headset. Ability to travel 30% of working time away from work location, may include overnight/weekend travel. Minimum Qualifications Bachelor's degree in Physical or Life Sciences; or a High School Diploma/ General Education Degree (GED) and at least 5 years of relevant career experience in lieu of Bachelor's degree. 7+ years relevant experience in a regulated pharmaceutical or medical device environment. Basic computer skills to include Internet navigation, Email usage, and word processing. Proficient in Microsoft Office. Authorization to work in the European Union. Demonstrated ability to perform the Essential Duties of the position with or without accommodation. Preferred Qualifications Bachelor's degree in Science or Health related discipline. Professional working knowledge with reviewing and approving product advertising and creating product labeling. Professional working knowledge with adverse event reporting and is familiar with post-market surveillance and vigilance requirements. success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.to stay updated on the latest news and opportunities at Exact Sciences.
May 07, 2026
Full time
Lead Regulatory Affairs Manager, International page is loaded Lead Regulatory Affairs Manager, Internationallocations: DE - Cologne: UK - London: Sweden: IT - Milantime type: Full timeposted on: Posted Todayjob requisition id: R26-12786 Help us change lives At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others. Position Overview The Lead Regulatory Affairs Manager, International will support or lead the creation and submission of product Technical Files/Standard Technical Documentation and other submission related documents for market authorizations in targeted markets and countries. The Lead Regulatory Affairs Manager, International supports or leads the creation and execution of regulatory strategy for assigned projects, including new product development, product changes, and manufacturing improvement initiatives. This role assists in creating, developing, and implementing global regulatory affairs procedures and educating others on global regulatory expectations and requirements. Essential Duties Include but are not limited to the following: Participate, lead or support the preparation and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution approvals and/or clearances. Support or lead as needed regulatory strategy development, document appropriate regulatory strategy for proposed new products and markets and initiate necessary activities by working with project teams and regulatory team members as needed. Control and maintain regulatory records. Represent Regulatory Affairs on project teams by attending team meetings and providing the required plans, procedures and regulatory decisions. Manage distributors and RA consultants to ensure global registrations are completed on time and maintained. Review and approve documents and product changes for regulatory compliance, determining if a new premarket application is required. Review technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry. Review and approve product labeling and marketing material. Provide Regulatory reviews and approvals of advertising, promotional and external product training materials in compliance with applicable regulatory and trade requirements and Exact Sciences Medical, Legal and Regulatory (MLR) review process. Demonstrate continuous pursuit of global regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including IVDR, UK CA, FDA and Health Canada regulations and policies applying to In Vitro Diagnostic medical devices including, PMAs, 510(k)s, labeling and promotional materials, global registration, and technical writing. Experience with regulators in the Middles East and/or Latin America will be a plus. Strong technical writing skills. Effective communicator: ability to convey messages in a logical and concise manner. Consistently reinforce regulatory expectations and requirements. Exceptional attention to detail. Strong organizational skills. Independent self-starter; manage time effectively and complete tasks on-time with minimal supervision. Flexible and able to self-manage multiple priorities. Ability to work effectively in multinational/multicultural environments. Adapt readily to changes in workload, staffing, and scheduling. Comply with management direction. Seek assistance from supervisor in identifying and reporting problems or concerns relating to job functions. Conduct self in a professional manner with coworkers, management, customers, and others. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company's Quality Management System policies and procedures. Regular and reliable attendance. Ability to work designated schedule. Ability to work nights and/or weekends as needed. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 75% of a typical working day. Ability to work on a computer and phone simultaneously. Ability to use a telephone through a headset. Ability to travel 30% of working time away from work location, may include overnight/weekend travel. Minimum Qualifications Bachelor's degree in Physical or Life Sciences; or a High School Diploma/ General Education Degree (GED) and at least 5 years of relevant career experience in lieu of Bachelor's degree. 7+ years relevant experience in a regulated pharmaceutical or medical device environment. Basic computer skills to include Internet navigation, Email usage, and word processing. Proficient in Microsoft Office. Authorization to work in the European Union. Demonstrated ability to perform the Essential Duties of the position with or without accommodation. Preferred Qualifications Bachelor's degree in Science or Health related discipline. Professional working knowledge with reviewing and approving product advertising and creating product labeling. Professional working knowledge with adverse event reporting and is familiar with post-market surveillance and vigilance requirements. success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.to stay updated on the latest news and opportunities at Exact Sciences.
A leading cancer diagnostics company is seeking a Lead Regulatory Affairs Manager to oversee the regulatory submissions and compliance for medical products across international markets. You will lead the creation of regulatory strategies and manage documentation and submissions for market authorizations. The ideal candidate will have 7+ years in a regulated environment, strong communication skills, and the ability to work effectively in diverse teams. This role is based in London and requires travel up to 30%.
May 07, 2026
Full time
A leading cancer diagnostics company is seeking a Lead Regulatory Affairs Manager to oversee the regulatory submissions and compliance for medical products across international markets. You will lead the creation of regulatory strategies and manage documentation and submissions for market authorizations. The ideal candidate will have 7+ years in a regulated environment, strong communication skills, and the ability to work effectively in diverse teams. This role is based in London and requires travel up to 30%.
Cure Talent are delighted to be partnered with a global medical device organisation recognised as one of the most established and successful healthcare companies in the world. With a diverse international footprint and a strong pipeline of innovation, the business continues to invest heavily in next-generation technologies and regulatory excellence. We have an opportunity for a Regulatory Affairs Manager to lead the EU Regulatory Strategy for a brand new Class III medical device. This is a strategically significant role within a highly experienced global regulatory function. As the Regulatory Affairs Manager, you will define and drive the EU regulatory pathway under MDR 2017/745 for a new product programme. You will lead regulatory strategy development from early-stage development through to submission and approval, ensuring alignment with global regulatory, clinical and R&D teams. This position is centred on regulatory project leadership rather than line management. While there is no direct people management initially, the scope and visibility of the programme offers long-term progression potential. To be successful as the new Regulatory Affairs Manager, you will bring proven experience leading EU regulatory strategy for Class III medical devices, ideally within a structured global organisation. You will be confident defining approval pathways under MDR 2017/745, comfortable operating at project leadership level across R&D, Clinical and global Regulatory teams, and experienced in managing Notified Body interactions. You will combine technical depth with the ability to influence stakeholders, manage complex timelines and take ownership of a high-visibility regulatory programme from concept through to approval. Key Responsibilities Define and own the EU regulatory strategy for a new Class III device under MDR. Lead regulatory project management activities, integrating with global RA, Clinical Affairs and R&D teams. Develop and maintain regulatory plans aligned to product development milestones. Lead Notified Body strategy and manage regulatory interactions. Provide regulatory input into design, risk management, clinical strategy and technical documentation. Support audits and ensure ongoing compliance with ISO 13485 and applicable regulations. Experience and Skills Required Proven experience within Regulatory Affairs in medical devices. Direct experience with Class III devices is essential. Demonstrated leadership of regulatory strategy for new product development programmes is essential. Strong working knowledge of EU MDR 2017/745 and associated regulatory frameworks. Experience interacting with Notified Bodies and Competent Authorities. Experience across additional regions such as US or other international markets is highly desirable but not essential. Degree in a relevant scientific or engineering discipline. This is a high-impact opportunity within a globally recognised organisation where regulatory strategy sits at the heart of product success. It will suit a regulatory professional who enjoys ownership, structured project delivery and operating within a large, well-resourced international environment. If you would like to discuss this opportunity in confidence, we would welcome a conversation.
May 07, 2026
Full time
Cure Talent are delighted to be partnered with a global medical device organisation recognised as one of the most established and successful healthcare companies in the world. With a diverse international footprint and a strong pipeline of innovation, the business continues to invest heavily in next-generation technologies and regulatory excellence. We have an opportunity for a Regulatory Affairs Manager to lead the EU Regulatory Strategy for a brand new Class III medical device. This is a strategically significant role within a highly experienced global regulatory function. As the Regulatory Affairs Manager, you will define and drive the EU regulatory pathway under MDR 2017/745 for a new product programme. You will lead regulatory strategy development from early-stage development through to submission and approval, ensuring alignment with global regulatory, clinical and R&D teams. This position is centred on regulatory project leadership rather than line management. While there is no direct people management initially, the scope and visibility of the programme offers long-term progression potential. To be successful as the new Regulatory Affairs Manager, you will bring proven experience leading EU regulatory strategy for Class III medical devices, ideally within a structured global organisation. You will be confident defining approval pathways under MDR 2017/745, comfortable operating at project leadership level across R&D, Clinical and global Regulatory teams, and experienced in managing Notified Body interactions. You will combine technical depth with the ability to influence stakeholders, manage complex timelines and take ownership of a high-visibility regulatory programme from concept through to approval. Key Responsibilities Define and own the EU regulatory strategy for a new Class III device under MDR. Lead regulatory project management activities, integrating with global RA, Clinical Affairs and R&D teams. Develop and maintain regulatory plans aligned to product development milestones. Lead Notified Body strategy and manage regulatory interactions. Provide regulatory input into design, risk management, clinical strategy and technical documentation. Support audits and ensure ongoing compliance with ISO 13485 and applicable regulations. Experience and Skills Required Proven experience within Regulatory Affairs in medical devices. Direct experience with Class III devices is essential. Demonstrated leadership of regulatory strategy for new product development programmes is essential. Strong working knowledge of EU MDR 2017/745 and associated regulatory frameworks. Experience interacting with Notified Bodies and Competent Authorities. Experience across additional regions such as US or other international markets is highly desirable but not essential. Degree in a relevant scientific or engineering discipline. This is a high-impact opportunity within a globally recognised organisation where regulatory strategy sits at the heart of product success. It will suit a regulatory professional who enjoys ownership, structured project delivery and operating within a large, well-resourced international environment. If you would like to discuss this opportunity in confidence, we would welcome a conversation.
Primary Location :BIGGLESWADE, United KingdomAt Solina, our community of close to 5,000 people share a passion for food and live our entrepreneurial culture.We design customised savoury solutions for our clients operating in the food industry, food service, butchery and nutrition markets. With sustainability at the heart of our business model, we aim to produce food that is good in every sense of the word: delicious, nourishing, affordable, sustainable and convenient.Solina is a fast-growing business, with around 50 production sites and R&D laboratories present in more than 19 countries mainly in Europe and North America.By constantly rethinking culinary solutions, we make food matter for people and the planet . If you're ready for a new adventure in a dynamic, expanding, passionate, international company, join us !We are looking for an experienced Group Supplier Quality Assurance Manager to define and lead our vendor quality and food safety strategy across Europe and North America .In this pivotal role, you will shape how we work with suppliers at Group level, ensuring robust quality, food safety, regulatory compliance, and responsible sourcing , while actively supporting major procurement and digital transformation initiatives . You will play a key role in enabling supplier consolidation, complexity reduction, supply continuity, and long term resilience.As a member of the Group Quality Leadership Team and reporting to the Group Quality Director , you will act as a senior partner to Procurement, Sustainability, Operations, R&D, Regulatory Affairs, and external vendors. You will lead the evolution towards a risk based, value driven supplier governance model , supporting business growth, M&A integration, and increasing regulatory and customer expectations. Your responsibilities will include: Defining and deploying the Group Supplier Quality Assurance strategy aligned with our overaal Quality, Food Safety, Procurement, and ESG ambitions Establishing clear Group policies, standards, and governance frameworks for vendor approval, monitoring, escalation, and performance Acting as Quality & Food Safety lead for procurement transformation programs, ensuring supplier changes are robustly assessed Leading vendor risk management , crisis preparedness, and incident response related to supplier quality, food safety, or supply continuity Driving continuous improvement and performance management with strategic and preferred suppliers Building and leading the Group Supplier Quality community , strengthening capabilities across regionsThis is a highly visible role combining strategy, execution, leadership, and influence in a complex, international environment. Candidate's profile We are looking for a senior quality leader with strong credibility in multinational, matrix organisations. Master's degree in Food Science, Quality, or a related field 15+ years of experience in Quality roles within food, ingredients, or FMCG Proven experience at senior management in an international organisation Strong background in supplier audits, risk management, and food safety standards (BRCGS, IFS, FSSC 22000) Solid understanding of regulatory requirements and emerging EU regulations , as well as sustainability frameworks Demonstrated experience with vendor consolidation, harmonisation, dual sourcing, and change programmes Experience working across Europe and North America is a strong asset Strategic mindset combined with strong execution capability Excellent influencing skills, particularly in procurement driven environments, collaborative, pragmatic, and partnership oriented mindset Ability to balance standardization with pragmatic regional adaptation Strong leadership presence and credibility with senior stakeholder, proven crisis leadership and change management skills Location The preferred location is one of the following Solina sites: Biggleswade (UK), Bolingbrook (USA), Malmö (Sweden), or Eastvale (USA). The role involves frequent travel within Europe and North America. We are open to talents of all backgrounds. Our recruitment process is based on competences, and we openly welcome all candidates of all types according to our DEI Commitment Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.
May 03, 2026
Full time
Primary Location :BIGGLESWADE, United KingdomAt Solina, our community of close to 5,000 people share a passion for food and live our entrepreneurial culture.We design customised savoury solutions for our clients operating in the food industry, food service, butchery and nutrition markets. With sustainability at the heart of our business model, we aim to produce food that is good in every sense of the word: delicious, nourishing, affordable, sustainable and convenient.Solina is a fast-growing business, with around 50 production sites and R&D laboratories present in more than 19 countries mainly in Europe and North America.By constantly rethinking culinary solutions, we make food matter for people and the planet . If you're ready for a new adventure in a dynamic, expanding, passionate, international company, join us !We are looking for an experienced Group Supplier Quality Assurance Manager to define and lead our vendor quality and food safety strategy across Europe and North America .In this pivotal role, you will shape how we work with suppliers at Group level, ensuring robust quality, food safety, regulatory compliance, and responsible sourcing , while actively supporting major procurement and digital transformation initiatives . You will play a key role in enabling supplier consolidation, complexity reduction, supply continuity, and long term resilience.As a member of the Group Quality Leadership Team and reporting to the Group Quality Director , you will act as a senior partner to Procurement, Sustainability, Operations, R&D, Regulatory Affairs, and external vendors. You will lead the evolution towards a risk based, value driven supplier governance model , supporting business growth, M&A integration, and increasing regulatory and customer expectations. Your responsibilities will include: Defining and deploying the Group Supplier Quality Assurance strategy aligned with our overaal Quality, Food Safety, Procurement, and ESG ambitions Establishing clear Group policies, standards, and governance frameworks for vendor approval, monitoring, escalation, and performance Acting as Quality & Food Safety lead for procurement transformation programs, ensuring supplier changes are robustly assessed Leading vendor risk management , crisis preparedness, and incident response related to supplier quality, food safety, or supply continuity Driving continuous improvement and performance management with strategic and preferred suppliers Building and leading the Group Supplier Quality community , strengthening capabilities across regionsThis is a highly visible role combining strategy, execution, leadership, and influence in a complex, international environment. Candidate's profile We are looking for a senior quality leader with strong credibility in multinational, matrix organisations. Master's degree in Food Science, Quality, or a related field 15+ years of experience in Quality roles within food, ingredients, or FMCG Proven experience at senior management in an international organisation Strong background in supplier audits, risk management, and food safety standards (BRCGS, IFS, FSSC 22000) Solid understanding of regulatory requirements and emerging EU regulations , as well as sustainability frameworks Demonstrated experience with vendor consolidation, harmonisation, dual sourcing, and change programmes Experience working across Europe and North America is a strong asset Strategic mindset combined with strong execution capability Excellent influencing skills, particularly in procurement driven environments, collaborative, pragmatic, and partnership oriented mindset Ability to balance standardization with pragmatic regional adaptation Strong leadership presence and credibility with senior stakeholder, proven crisis leadership and change management skills Location The preferred location is one of the following Solina sites: Biggleswade (UK), Bolingbrook (USA), Malmö (Sweden), or Eastvale (USA). The role involves frequent travel within Europe and North America. We are open to talents of all backgrounds. Our recruitment process is based on competences, and we openly welcome all candidates of all types according to our DEI Commitment Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.
The Senior Clinical Trial Manager will be responsible for managing clinical trial sites from study startup throughout the course of the clinical trials until site close out. They will work to oversee that all aspects of the conduct of the trial sites and or across their assigned assets are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. They will work collaboratively with the Sponsor Clinical Project Manager (CPM), Clinical Research Organization (CRO) representative(s), vendors and other Sponsor functional departments (as required) to drive start-up and ongoing oversight of clinical studies. They may have direct reports of Clinical Trial Managers across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost and quality. Responsabilities: Participate in the planning, implementation and management of sponsor clinical trials/assets in compliance with industry regulations, ICH-GCP and applicable sponsor controlled documents. Oversee the site management of CROs and clinical trial sites to ensure delivery, per scope of work or contractual agreements, meet recruitment targets and deliver high quality data on time. Track site visit and trip report metrics; data quality concerns and site level trending of protocol deviations. Conduct oversight site visits including pharmacy visits, as required, to evaluate site and CRA performance and ensure adherence to study protocols, study operation plans, ICH GCP and regulatory requirements Attend and assist, as required, at Initiation visits to confirm site training of therapeutic indication(s) and associated study procedures (e.g. Pharmacy training) and help build and foster sponsor-CRO-Investigator - site relationships Review a percentage of CRA monitoring trip reports, ensuring oversight of CRO CRA and Site compliance with protocol, study plans, SOPs and ICH and GCPs, escalate identified report issues and ensure CRO study team resolve identified concerns • Collaborate with sponsor CPM and sponsor Medical Monitor for country and site identification, feasibility and selection to optimize processes to ensure efficient start-up timelines are met. Manage study start up in collaboration with internal and external project teams (e.g. sponsor Project Manager, Regulatory, Clinical Supplies, Third Party Vendors, CRO) to ensure start up timelines are clearly defined and implemented, working to identify any risks and resolving any issues. Act as subject matter expert for assigned protocols for study related issues, protocol and clinical operational queries arising from CRO, IRB/IECs/RAs, Third Party Vendors and sites. Provide routine updates to the internal project team on study status/issues Manages the CRO/clinical trial site during start-up activities including, but not limited to, budget and contract negotiations, IRB/EC submissions and response and facilitation of essential document collection Provide direction and support to the CPM in ensuring consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate. Manages consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate Works cross-functionally with other sponsor departments (Clinical Supplies, Quality Assurance, Regulatory Affairs) to ensure all clinical trial activities performed by sponsor as a Sponsor are performed according to study requirements and timelines. Contribute to the development and/or participate in the review of study related documents including (but not limited to) site feasibility, protocol, informed consent documents (master and/or site specific), budgets, monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals, case report form development and training materials Execute and/or deliver trial specific training as required Review of open action items and data trends; working with CROs to escalate and resolve identified issues to ensure standards for monitoring and reporting are met as well as to ensure better efficiencies and execution of our studies Contribute to the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Support study team with site selection while optimizing start-up processes to ensure efficient start-up timelines are met. Attend and present at Investigator Meetings on Clinical Operations topics, as required May oversee the accurate, timely, and complete tracking of laboratory samples May represent Clinical Operations in cross-functional initiatives (e.g., start-up, continued process improvements with CROs). Contribute to the development and/or participate in the review of sponsor SOPs, Work Instructions and team policies Contribute to preparation of investigator newsletters or email newsflashes. Supports the internal and external project teams with audits/inspection readiness and activities, resolution of audit/inspection findings and contribution to CAPAs as required Oversight of direct report(s) study execution and procedures as required to ensure regulatory compliance of protocol activities, if appropriate Accountable for ensuring all study deliverables and milestones are met with quality and within timelines Provide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets Provides support/escalation point for direct reports as needed Profile: At least 8 years of relevant clinical operational experience in a biotechnology/pharmaceutical company, and/or CRO Working knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus Experience with start-up and initiation of clinical trial sites Experience creating and maintaining healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required Ability to communicate and coordinate activities with the internal team, clinical sites and vendors Proactively identify project challenges/risks and appropriate corrective actions to the internal study teams and work with internal team, clinical sites and vendors on resolutions with minimal supervision Ability to work independently Experience presenting high level presentations, both orally and in writing Knowledge of and experience with immunotherapies and/or Oncology At least 2 years of on-site monitoring experience IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Oct 06, 2025
Full time
The Senior Clinical Trial Manager will be responsible for managing clinical trial sites from study startup throughout the course of the clinical trials until site close out. They will work to oversee that all aspects of the conduct of the trial sites and or across their assigned assets are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. They will work collaboratively with the Sponsor Clinical Project Manager (CPM), Clinical Research Organization (CRO) representative(s), vendors and other Sponsor functional departments (as required) to drive start-up and ongoing oversight of clinical studies. They may have direct reports of Clinical Trial Managers across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost and quality. Responsabilities: Participate in the planning, implementation and management of sponsor clinical trials/assets in compliance with industry regulations, ICH-GCP and applicable sponsor controlled documents. Oversee the site management of CROs and clinical trial sites to ensure delivery, per scope of work or contractual agreements, meet recruitment targets and deliver high quality data on time. Track site visit and trip report metrics; data quality concerns and site level trending of protocol deviations. Conduct oversight site visits including pharmacy visits, as required, to evaluate site and CRA performance and ensure adherence to study protocols, study operation plans, ICH GCP and regulatory requirements Attend and assist, as required, at Initiation visits to confirm site training of therapeutic indication(s) and associated study procedures (e.g. Pharmacy training) and help build and foster sponsor-CRO-Investigator - site relationships Review a percentage of CRA monitoring trip reports, ensuring oversight of CRO CRA and Site compliance with protocol, study plans, SOPs and ICH and GCPs, escalate identified report issues and ensure CRO study team resolve identified concerns • Collaborate with sponsor CPM and sponsor Medical Monitor for country and site identification, feasibility and selection to optimize processes to ensure efficient start-up timelines are met. Manage study start up in collaboration with internal and external project teams (e.g. sponsor Project Manager, Regulatory, Clinical Supplies, Third Party Vendors, CRO) to ensure start up timelines are clearly defined and implemented, working to identify any risks and resolving any issues. Act as subject matter expert for assigned protocols for study related issues, protocol and clinical operational queries arising from CRO, IRB/IECs/RAs, Third Party Vendors and sites. Provide routine updates to the internal project team on study status/issues Manages the CRO/clinical trial site during start-up activities including, but not limited to, budget and contract negotiations, IRB/EC submissions and response and facilitation of essential document collection Provide direction and support to the CPM in ensuring consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate. Manages consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate Works cross-functionally with other sponsor departments (Clinical Supplies, Quality Assurance, Regulatory Affairs) to ensure all clinical trial activities performed by sponsor as a Sponsor are performed according to study requirements and timelines. Contribute to the development and/or participate in the review of study related documents including (but not limited to) site feasibility, protocol, informed consent documents (master and/or site specific), budgets, monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals, case report form development and training materials Execute and/or deliver trial specific training as required Review of open action items and data trends; working with CROs to escalate and resolve identified issues to ensure standards for monitoring and reporting are met as well as to ensure better efficiencies and execution of our studies Contribute to the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Support study team with site selection while optimizing start-up processes to ensure efficient start-up timelines are met. Attend and present at Investigator Meetings on Clinical Operations topics, as required May oversee the accurate, timely, and complete tracking of laboratory samples May represent Clinical Operations in cross-functional initiatives (e.g., start-up, continued process improvements with CROs). Contribute to the development and/or participate in the review of sponsor SOPs, Work Instructions and team policies Contribute to preparation of investigator newsletters or email newsflashes. Supports the internal and external project teams with audits/inspection readiness and activities, resolution of audit/inspection findings and contribution to CAPAs as required Oversight of direct report(s) study execution and procedures as required to ensure regulatory compliance of protocol activities, if appropriate Accountable for ensuring all study deliverables and milestones are met with quality and within timelines Provide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets Provides support/escalation point for direct reports as needed Profile: At least 8 years of relevant clinical operational experience in a biotechnology/pharmaceutical company, and/or CRO Working knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus Experience with start-up and initiation of clinical trial sites Experience creating and maintaining healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required Ability to communicate and coordinate activities with the internal team, clinical sites and vendors Proactively identify project challenges/risks and appropriate corrective actions to the internal study teams and work with internal team, clinical sites and vendors on resolutions with minimal supervision Ability to work independently Experience presenting high level presentations, both orally and in writing Knowledge of and experience with immunotherapies and/or Oncology At least 2 years of on-site monitoring experience IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Regulatory Affairs & Quality Specialist - Home Based - FIXED TERM CONTRACT UNTIL END OF DECEMBER 2026 Now s our time to inspire the future of healthcare together. Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 66,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us. Do you have regulatory experience, and are you seeking a new job? Siemens Healthineers is looking for a full-time Regulatory Affairs Specialist on a Fixed Term Contract basis until the end of 2026 to cover a period of maternity leave, offering a competitive salary and benefits package and the opportunity to further build your experience in a leading organisation. As a Regulatory Affairs Specialist, you will provide regulatory support to the European Authorised Representative (EU AR) team on a day to day basis. This role reports to and supports the EU Authorised Representative Manager to ensure compliance to the requirements of IVDR Regulation (EU) 2017/746, UK regulation (MDR 2002), as well as other relevant global regulatory framework. This team works closely with other departments providing regulatory / quality support in a manner that is consistent with the company's Business Principles. Your Role: In relation to OUS Field Actions for the Diagnostics Business Line, liaise with legal Manufacturers and country Quality Teams, provide reporting recommendation, review approve and distribute documents. To provide Diagnostics Quality with feedback / questions and ensure closure for each Field Action. Where applicable, to complete reporting activities in accordance with IVDR Article 87(7) and UK MDR (Regulations 44ZJ and Regulation 44ZK) Co-ordinate OUS Field Action enquiries Be a Point of Contact for EU AR / UK Responsible Person on behalf of the US & UK legal Manufacturers Your Experience: To apply for this role, you will need knowledge of compliance with key international standards (i.e. ISO 13485, FDA regulations, European Directives and Regulations) and with regulatory requirements worldwide (preferable but not mandatory) Degree qualification in a relevant discipline (Regulatory Affairs or Quality degree is desirable but not mandatory) and/or appropriate professional experience gained working in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices. Proven experience in a regulatory role, preferably in the in-vitro diagnostics industry, although other medical devices background will also be considered Proficient in Microsoft Office (including Outlook, Excel, Word, SharePoint, etc) Promote excellence and embrace right first time culture. A strong understanding of the need for accuracy Work efficiently and be self-disciplined To work well under pressure and to be able to identify the need to prioritise when required To be a dynamic team player who displays problem solving skills, who can work effectively and proactively on activities both individually and within a team Good communicator fluent in English in both speaking and writing with strong organisational skills Benefits: Competitive basic salary Up to 10% matched pension contributions BUPA Private Medical Cover Bonus 26 days annual leave (with the option to buy/sell up to 5) + bank holidays A range of additional salary sacrifice benefits including global travel insurance and dental cover to name a few How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. As an equal opportunity employer, we welcome applications from individuals with disabilities. We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. Please create a profile within our talent community and subscribe to personalized job alert that will keep you posted about new opportunities. To all recruitment agencies: Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.
Oct 03, 2025
Contractor
Regulatory Affairs & Quality Specialist - Home Based - FIXED TERM CONTRACT UNTIL END OF DECEMBER 2026 Now s our time to inspire the future of healthcare together. Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 66,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us. Do you have regulatory experience, and are you seeking a new job? Siemens Healthineers is looking for a full-time Regulatory Affairs Specialist on a Fixed Term Contract basis until the end of 2026 to cover a period of maternity leave, offering a competitive salary and benefits package and the opportunity to further build your experience in a leading organisation. As a Regulatory Affairs Specialist, you will provide regulatory support to the European Authorised Representative (EU AR) team on a day to day basis. This role reports to and supports the EU Authorised Representative Manager to ensure compliance to the requirements of IVDR Regulation (EU) 2017/746, UK regulation (MDR 2002), as well as other relevant global regulatory framework. This team works closely with other departments providing regulatory / quality support in a manner that is consistent with the company's Business Principles. Your Role: In relation to OUS Field Actions for the Diagnostics Business Line, liaise with legal Manufacturers and country Quality Teams, provide reporting recommendation, review approve and distribute documents. To provide Diagnostics Quality with feedback / questions and ensure closure for each Field Action. Where applicable, to complete reporting activities in accordance with IVDR Article 87(7) and UK MDR (Regulations 44ZJ and Regulation 44ZK) Co-ordinate OUS Field Action enquiries Be a Point of Contact for EU AR / UK Responsible Person on behalf of the US & UK legal Manufacturers Your Experience: To apply for this role, you will need knowledge of compliance with key international standards (i.e. ISO 13485, FDA regulations, European Directives and Regulations) and with regulatory requirements worldwide (preferable but not mandatory) Degree qualification in a relevant discipline (Regulatory Affairs or Quality degree is desirable but not mandatory) and/or appropriate professional experience gained working in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices. Proven experience in a regulatory role, preferably in the in-vitro diagnostics industry, although other medical devices background will also be considered Proficient in Microsoft Office (including Outlook, Excel, Word, SharePoint, etc) Promote excellence and embrace right first time culture. A strong understanding of the need for accuracy Work efficiently and be self-disciplined To work well under pressure and to be able to identify the need to prioritise when required To be a dynamic team player who displays problem solving skills, who can work effectively and proactively on activities both individually and within a team Good communicator fluent in English in both speaking and writing with strong organisational skills Benefits: Competitive basic salary Up to 10% matched pension contributions BUPA Private Medical Cover Bonus 26 days annual leave (with the option to buy/sell up to 5) + bank holidays A range of additional salary sacrifice benefits including global travel insurance and dental cover to name a few How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. As an equal opportunity employer, we welcome applications from individuals with disabilities. We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. Please create a profile within our talent community and subscribe to personalized job alert that will keep you posted about new opportunities. To all recruitment agencies: Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.
