Clinical Affairs Associate - Medical Devices

Clinical Affairs Associate (Medical Writing)

North Yorkshire with hybrid working

Everything you need to know about the role:

This is an opportunity to join a growing medical device organisation as a Clinical Affairs Associate, supporting the full clinical lifecycle of medical devices. The role plays a key part in clinical documentation, post-market surveillance (PMS), and post-market clinical follow-up (PMCF), working closely with regulatory, quality, and cross-functional stakeholders to ensure ongoing compliance and successful product support.

You’ll be involved in both pre- and post-market activities, contributing to technical documentation, audits, and new product development projects within a collaborative and quality-driven environment.

You will:

• Evaluate and analyse clinical evidence from literature, clinical investigations, PMS and PMCF activities
• Prepare and maintain clinical documentation, including Clinical Evaluation Plans and Reports
• Develop post-market documentation such as PMS plans, PMS reports, PSURs, and PMCF plans and evaluation reports
• Maintain and analyse post-market surveillance survey data
• Ensure compliance with applicable regulations, guidance, and internal SOPs
• Provide clinical input into risk management files, labelling, IFUs, marketing materials, and patient information
• Support claim substantiation and maintenance of device claims
• Support internal and external audits, including QMS audits
• Support vigilance, complaints handling, change control, and internal database maintenance

Experience and qualities that make you a strong fit:

• Experience within the medical devices sector
• Strong clinical or medical writing experience
• Working knowledge of MDR, MDD, UK MDR, IVDR/IVDD and relevant ISO standards
• Experience preparing and maintaining clinical evaluations and post-market documentation
• Ability to interpret clinical data, literature, and regulatory requirements
• Highly organised with strong attention to detail

Preferred:

• Experience with market submissions and regulatory approvals
• Hands-on involvement in PMCF and PMS activities
• Experience supporting or managing clinical studies
• Exposure to internal and external audits
• Experience compiling technical dossiers and working to MEDDEV/MDCG guidance
• Working knowledge of ISO 14971 risk management

What’s on offer:

• A varied and hands-on clinical affairs role within a growing medical device business
• Exposure to the full product lifecycle, from development through post-market
• Opportunities to work cross-functionally and develop regulatory and clinical expertise
• Supportive team environment with scope for professional development

Could this be the role for you?

If you enjoy clinical writing, thrive in regulated environments, and want to build or deepen your career in medical device clinical affairs, this role offers the chance to make a real impact across multiple products and projects.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.
Carrot Recruitment acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, colour, sex, age, national origin, religion, sexual orientation, gender identity and/or expression.

If there are any arrangements or adjustments we can make to assist you at interview then please let us know and we’ll be more than happy to assist.