Clinical Specialist - Medical Devices | Remote

20 Days Old

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:
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Leading and supporting clinical evaluation and PMCF activities for medical devices from planning through to final reporting
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Managing clinical and HFE studies, ensuring delivery aligns with timelines, budgets, and regulatory expectations
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Providing clinical input across product development, design changes, manufacturing updates, and post-market surveillance
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Contributing to Clinical Evaluation Reports (CERs), PMCF plans, protocols, and technical documentation
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Interpreting global clinical and regulatory requirements, including ISO 13485, MDR 2017/745, FDA, ISO 14155, and ISO 14971
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Advising cross-functional teams on clinical data needs to support regulatory submissions and product claims
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Identifying clinical risks, usage challenges, and emerging issues, recommending practical mitigation strategies
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Supporting updates to clinical procedures, templates, and best practices
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Assisting with internal training on clinical and regulatory compliance topics
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Working with external partners and vendors where required to deliver clinical activities
To be successful as a Clinical Specialist, you will need:
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Experience within a medical devices organisation operating under ISO 13485
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Practical knowledge of MDR 2017/745 (and/or MDD), FDA requirements, and clinical standards such as ISO 14155 and ISO 14971
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Background in clinical evaluation, PMCF, or related regulatory clinical activities
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Strong written skills, with experience preparing clinical documentation and reports
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Ability to manage multiple priorities and contribute effectively to cross-functional project teams
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Confident communication skills, with the ability to influence and advise technical and non-technical stakeholders
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Experience working in fast-paced, regulated environments; international exposure is advantageous
Why join this opportunity?
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Work on globally distributed medical devices within a well-established regulatory framework
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Gain exposure to full lifecycle clinical strategy, PMCF, and HFE activities
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Join a collaborative, forward-thinking clinical and regulatory team
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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
Apply
Location:
Nationwide
Salary:
£40,000 - £56,000 /annum
Job Type:
FullTime
Category:
Medical/Pharmaceutical/Scientific

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