Clinical Specialist - Medical Devices Remote

A leading medical device manufacturer in South Wales is expanding its Regulatory & Clinical function and is seeking a Clinical Specialist to support clinical and post-market activities across a global product portfolio.

This role sits at the centre of clinical strategy and delivery, supporting clinical evaluation, PMCF, and human factors engineering (HFE) activities within a highly regulated ISO 13485 and MDR 2017/745 environment. As a Clinical Specialist, you will collaborate closely with Regulatory Affairs, R&D, Quality, Manufacturing, and Marketing to ensure products remain clinically compliant and market-ready throughout their lifecycle.

Your responsibilities as a Clinical Specialist will include:

• Leading and supporting clinical evaluation and PMCF activities for medical devices from planning through to final reporting

• Managing clinical and HFE studies, ensuring delivery aligns with timelines, budgets, and regulatory expectations

• Providing clinical input across product development, design changes, manufacturing updates, and post-market surveillance

• Contributing to Clinical Evaluation Reports (CERs), PMCF plans, protocols, and technical documentation

• Interpreting global clinical and regulatory requirements, including ISO 13485, MDR 2017/745, FDA, ISO 14155, and ISO 14971

• Advising cross-functional teams on clinical data needs to support regulatory submissions and product claims

• Identifying clinical risks, usage challenges, and emerging issues, recommending practical mitigation strategies

• Supporting updates to clinical procedures, templates, and best practices

• Assisting with internal training on clinical and regulatory compliance topics

• Working with external partners and vendors where required to deliver clinical activities

To be successful as a Clinical Specialist, you will need:

• Experience within a medical devices organisation operating under ISO 13485

• Practical knowledge of MDR 2017/745 (and/or MDD), FDA requirements, and clinical standards such as ISO 14155 and ISO 14971

• Background in clinical evaluation, PMCF, or related regulatory clinical activities

• Strong written skills, with experience preparing clinical documentation and reports

• Ability to manage multiple priorities and contribute effectively to cross-functional project teams

• Confident communication skills, with the ability to influence and advise technical and non-technical stakeholders

• Experience working in fast-paced, regulated environments; international exposure is advantageous
  

Why join this opportunity?

• Work on globally distributed medical devices within a well-established regulatory framework

• Gain exposure to full lifecycle clinical strategy, PMCF, and HFE activities

• Join a collaborative, forward-thinking clinical and regulatory team

• The company supports continuous learning and career progression.

Please note, applicants must already have the right to work in the UK, as visa sponsorship is not available.

Clinical Specialist Clinical Associate Medical Devices ISO 13485 MDR 2017/745 PMCF HFE Clinical Evaluation CER Regulatory Clinical Jobs Remote