AliveDX

REGULATORY AFFAIRS OFFICER AliveDx are recruiting a Regulatory Affairs Officer to join the Regulatory Affairs team based near Edinburgh (EH26 0BF). The role is responsible for building regulatory strategy, to determine applicable regulatory requirements, propose solutions to comply with regulatory requirements manage product license registration with the appropriate regulatory authorities worldwide. Furthermore, the role is responsible for providing guidance to the company on regulatory requirements and aspects. YOUR MISSION Your main responsibilities will include: Advise AliveDx staff and project team members on data and information required for successful license applications and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission. Prepare and compile regulatory documentation, coordinate and execute regulatory submission for countries including US, EU, Canada and any other territories as appropriate in compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Canadian Medical Device Regulations (CMDR) - Part 1 and other country requirements as appropriate. Develop product labelling regulatory requirements for AliveDx products and for customer contracted products including but not limited to package labels, product labels and instructions for use. Liaise with internal and external parties as required to support development of product labelling. Contribute to the regulatory watch process by maintaining knowledge of new or update regulatory requirements, guidance documents and industry standards. Ensure maintenance of product regulatory documents and technical files (including US, EU, Japan, Brazil, Canada) to ensure ongoing compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs) Biologics License Applications (BLA), Medical Device Approvals (510(k), Canadian Medical Device Regulations (CMDR) - Part 1 and other non-registered product requirements to support compliance for Quotient and its products. Liaise with regulatory authorities and external contract bodies and, in response to requests from these, collate and interpret specialised information. Ensure that changes are documented in accordance with quality system requirements and are communicated on a timely basis, as appropriate, to the Regulatory Authorities. YOUR COMPETENCIES A relevant degree and/or relevant work experience in a regulatory affairs environment. Experience in medical device/IVD/Biotech industry Experienced in meeting with, making presentations to, and negotiating with regulators Previous experience preparing and submitting BLA, 510(k), PMA, CE mark and technical files to other worldwide regulatory authorities. Great attention to detail, communication and collaboration skills. WHAT WE OFFER Ahighly dynamic and growing environment. An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do. A flexible working environment where applicableanda range of core and flexible benefitsranging from pension, private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days and access to marketplace discounts. Interested? We look forward to receiving your application. AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.

SENIOR REGULATORY AFFAIRS OFFICER AliveDx is recruiting for a Senior Regulatory Affairs Officer to join the Regulatory Affairs Team based near Penicuik, Edinburgh. The role is a full time permanent position, working 37.5 hours. The Senior Regulatory Affairs Officer is responsible for leading and executing regulatory strategy for AliveDx products across multiple geographies. The role ensures the identification, interpretation and application of applicable regulatory requirements, proposes compliant regulatory solutions, and independently manages complex product license registrations and lifecycle activities worldwide. The role provides expert regulatory guidance to cross functional teams, acts as a key point of contact with regulatory authorities, and supports continuous improvement of regulatory systems and processes. The Senior Regulatory Affairs Officer also has responsibility for mentoring and supporting junior regulatory staff, contributing to capability development within the Regulatory Affairs function. YOUR MISSION Your main responsibilities will include: Prepare and maintain regulatory documentation and materials in compliance with Good Manufacturing Practice (cGMP), ISO13485, the IVD Directive 98/79/EC, the IVD Regulations (EU) 2017/746, FDA 21 Code of Federal Regulations (CFRs), Canadian Medical Device Regulations (CMDR) SOR/98-282 and any other applicable country specific regulations. The Senior Regulatory Affairs Officer will liaise with internal team members, regulatory agencies and external customers/distributors to provide information to support regulatory processes and to confirm compliance issues. Maintain excellent working knowledge of regulatory requirements, keeping abreast of updates to regulation worldwide and advise as appropriate. Liaise with any and all regulatory agencies and external customers/distributors/vendors to provide information to support regulatory processes and to confirm compliance issues. Advise project team members on regulatory requirements, data and information required for successful license applications, impact of changes to existing product and impact of non conformances and post market events.Ensure the accurate recording and satisfactory completion of all departmental documentation including documenting revisions through a change control process. Contribute to the design and implementation of new quality systems and procedures and identify areas for potential improvement to ensure continuous quality improvement is realised. Supervise colleagues within the Regulatory Affairs department, when required, by providing support and guidance as needed to knowledge across the team remains current. YOUR COMPETENCIES Previous experience of IVDR implementation plans and requirements. Experience of preparing and submitting regulatory applications in geographies outwith EU, US, Canada. WHAT WE OFFER A highly dynamic and growing environment. An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do. A flexible working environment where applicable and a range of core and flexible benefits ranging from private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days and access to marketplace discounts. INTERESTED? We look forward to receiving your application. AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline or discharge, will be based on competences, performance and business needs.

A medical device company near Edinburgh is looking for a Senior Regulatory Affairs Officer to lead regulatory strategy across multiple geographies. This full-time position involves preparing regulatory documentation, advising project teams, and providing expert regulatory guidance. The ideal candidate will have experience with IVDR implementation and be knowledgeable of regulatory requirements worldwide. Employees enjoy a flexible working environment with a variety of benefits including private medical cover and additional leave.