Clinical Specialist

Clinical Specialist – Medical Devices | Remote

A leading medical device manufacturer 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.

Responsibilities

• 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

Qualifications

• 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

Benefits

• 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.

You must have the right-to-work in the United Kingdom and sponsorship cannot be offered at this time.