Regulatory Affairs Manager

Who We Are at Drive Medical

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.

Leading the World with Innovative Solutions that Enhance Lives

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.

Key Responsibilities

• 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.

Skills & Experience

• 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.
• Knowledge of ISO 13485 ISO 9001 REACH RoHS and relevant UK/EU regulations.
• Strong leadership communication organisational and report-writing skills.
• Experience in risk management usability engineering clinical evaluation post-market surveillance and international standards.

Why Youll Love Working With Us

Were not sharing the salary just yet but its competitive and worth talking about. What really makes us stand out is how proud our team is of the work they do. We make sure that dedication is recognized not just with pay but with great benefits and support.

Heres what you can look forward to beyond the salary:

• Generous Annual Leave 26 days to start rising to 28 with service plus your birthday off every year! You can also buy sell or carry over leave to suit your lifestyle.
• 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.

*Eligibility for some benefits depends on length of service

Equal Opportunities Statement:

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.

We comply fully with all applicable legislation governing non-discrimination in every location where we operate. Our recruitment and selection processes are regularly reviewed to ensure fairness consistency and that all candidates are assessed solely on the basis of their skills qualifications and experience relevant to the role.

Please note: All successful applicants will be required to provide proof of their eligibility to work in the UK and supply accurate reference details covering their recent employment history. Certain roles may also be subject to an Enhanced DBS (Disclosure and Barring Service) or PVG (Protecting Vulnerable Groups) check.

Required Experience:

Manager