Full job description?
*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


*No Sponsorship offered