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 with in 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