Regulatory Affairs Specialist

• Regulatory Affairs Specialist
• Northern/ Central Cotswolds, Gloucestershire, UK - 2/3 days per week on site
• Full-time, Permanent Position
• £40,000 - £45,000 + DOE

Cpl Life Sciences is partnering with an established and growing medical device manufacturer to recruit a Regulatory Affairs Specialist. This is an excellent opportunity to join a collaborative regulatory team supporting innovative products across international markets.

As the Regulatory Affairs Specialist, you'll play a key role in maintaining global product compliance, managing technical documentation, and supporting regulatory submissions across Europe, the UK, FDA, and MDSAP regions.

Key Responsibilities:

• Develop and contribute to regulatory strategies for new products and product changes
• Create, maintain and manage Technical Files, Summary Technical Documentation and GSPR checklists
• Support CE Marking, UKCA marking and FDA clearance activities
• Prepare and submit documentation to Notified Bodies and respond to regulatory queries
• Support Clinical Evaluation Reports (CERs)
• Manage Post Market Surveillance activities
• Maintain Risk Management documentation
• Review and approve product labelling, packaging artwork and marketing materials
• Monitor evolving regulatory requirements and drive regulatory intelligence initiatives
• Support external audits and quality management system activities

About You:

• Minimum 3 years' experience in Medical Device Regulatory Affairs
• Strong understanding of EU MDR requirements and technical documentation
• Experience supporting CE Marking and interactions with Notified Bodies
• Knowledge of QMS processes and post-market activities would be advantageous
• Degree in Life Sciences or related discipline preferred
• Strong organisational skills with the ability to manage multiple projects simultaneously

For more information, please reach out to [email removed]

• No Sponsorship offered