Regulatory Affairs Manager - Medical Devices

Regulatory Affairs Manager – Medical Devices

North Yorkshire | Hybrid Working (2–3 days WFH)

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 deadlines
• Maintain 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.

Essential experience:

• 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

Desirable experience:

• 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.

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.