Regulatory Affairs Manager – Medical Devices
Are you ready to step into a Regulatory Affairs leadership role where you can genuinely shape strategy, lead people, and work with a super supportive, collaborative team?
We’re looking for an experienced Regulatory Affairs Manager to take ownership of regulatory strategy, registrations, and compliance across a diverse medical device portfolio, while leading and developing a growing RA team.
The Role
Reporting into the Head of Regulatory Affairs, you’ll be responsible for the end-to-end regulatory lifecycle of medical devices across the UK, EU, US and ROW markets. This is a hands‑on leadership role, blending people management, strategic planning, and technical regulatory expertise.
You’ll oversee regulatory submissions, certifications, and change notifications, while ensuring compliance with evolving global regulations including MDR, IVDR and UKCA.
Key Responsibilities
- Lead, mentor and develop a Regulatory Affairs team (direct and indirect reports)
- Own regulatory strategy for existing products and new device introductions
- Manage and maintain CE, UKCA, FDA (510k) and ROW registrations
- Oversee technical files, regulatory dossiers and conformity assessments
- Act as a key regulatory partner to R&D, Quality, Clinical, Marketing and Sales
- Track regulatory change controls, submissions and approvals to deadlinesMaintain internal and external regulatory databases (e.g. MHRA)
- Act as a key point of contact with regulatory authorities and notified bodies
- Support audits, PMS activities, UDI compliance and labelling approvals
- Drive continuous improvement in regulatory processes and systems
About You
You’ll be an experienced medical device regulatory professional who enjoys leading teams and navigating complex regulatory landscapes.
- Strong regulatory experience within medical devices (ideally 5+ years)
- Working knowledge of MDR, IVDR, UK MDR, ISO 13485
- Hands‑on experience with EU technical files (Class I–III)
- Experience with change notifications and regulatory authority interactions
- Proven people management and project management capability
- FDA 510(k) submissions
- ROW registrations
- UK Responsible Person / EU Importer knowledge
- Audit participation and QMS experience
- Clinical evaluation, PMS or PMCF exposure
Why Apply?
- Strategic leadership role with real influence
- Hybrid working: 2–3 days from home each week
- Collaborative, cross‑functional working environment. Everyone is very supportive and they foster a great working environment/culture.
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