Senior Manager/Director of Regulatory Affairs

Drive Medical has become a leading manufacturer of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. We are proud of our high-quality, diverse product portfolio, channel footprint and global operating scale. Our products are sold into the homecare, long-term care, retail, and e-commerce channels in more than 100 countries around the world.

We are seeking an experienced Regulatory Affairs Manager to lead and support our Regulatory Affairs team, ensuring Drive Medical products meet all applicable UK and European regulatory requirements. This role is responsible for overseeing the creation, maintenance, and compliance of medical device technical documentation while ensuring timely registration and regulatory submissions across relevant markets.

Operating within the UK Product Development team, you will provide technical leadership, support team development, and act as a key regulatory subject matter expert, helping Drive Medical maintain the highest standards of compliance, quality, and customer focus.

• Lead, mentor, and support the Regulatory Affairs team to deliver work effectively and on time.
• Oversee the creation, review, and maintenance of technical files in compliance with EU MDR and UK MDR requirements.
• Manage medical device registrations with the MHRA, EUDAMED, EU Authorised Representatives, and UK Responsible Person obligations.
• Conduct gap analyses of existing technical documentation and implement improvements to ensure ongoing compliance.
• Review and oversee regulatory documentation, including risk management files, usability engineering files, clinical evaluation reports, test reports, PMS documentation, and GSPR/Essential Requirements checklists.
• Identify and escalate regulatory risks, delays, and compliance concerns as appropriate.
• Provide regulatory guidance and support to internal stakeholders, customers, and suppliers.
• Drive continuous improvement within regulatory processes and departmental practices.

Proven experience in Regulatory Affairs within the medical device industry. Strong knowledge of EU MDR, UK MDR 2002 (as amended), and medical device technical file creation. Experience with Class I and Class IIa medical devices or higher. Strong leadership, communication, organisational, and report-writing skills. Experience in risk management, usability engineering, clinical evaluation, post-market surveillance, and international standards.

Generous Annual Leave 26 days to start, rising to 28 with service, plus your birthday off every year! Pension Scheme Helping you plan for a secure future. Employee Assistance Programme Free, confidential support for your mental, emotional, and financial well-being. Bike2Work Scheme Save money and stay healthy with tax-efficient bike purchases. Free Onsite Parking No stress, no extra cost. Long Service Recognition We celebrate your loyalty and contributions. Staff Discount Enjoy great savings on our products. Perkbox Access unlock a world of perks, discounts, and rewards to make life a little sweeter.

At Drive Medical, we are proud to be an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants, and we ensure that no individual is treated less favourably on the grounds of race, colour, nationality, ethnic or national origin, sex, marital or civil partnership status, religion or belief, age, sexual orientation, gender identity, or disability.

Certain roles may also be subject to an Enhanced DBS (Disclosure and Barring Service) or PVG (Protecting Vulnerable Groups) check.