- 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 protected]
- No Sponsorship offered