Regulatory Affairs Specialist

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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”

At Drive Medical, we put the customer at the heart of everything we do. Guided by our values of Integrity, Intent, Capability and Results, we are committed to delivering high-quality products and outstanding service. We are looking for a Regulatory Affairs Specialist to join our Regulatory Affairs team and play a key role in ensuring our medical devices meet all applicable UK, European and international regulatory requirements.

Reporting to the Regulatory Affairs Manager, you will be responsible for creating, reviewing and maintaining technical documentation to support regulatory compliance across our product portfolio. This is an excellent opportunity for a regulatory professional who enjoys working independently, collaborating across departments and contributing to the development of safe, compliant medical devices.

Key Responsibilities

• Create and maintain medical device technical files in line with EU MDR requirements and other applicable regulations.
• Review technical documentation to ensure ongoing compliance.
• Prepare, review and support key regulatory documents including:
• Clinical Evaluation Reports (CERs)
• Risk Management Files
• Usability Engineering Files
• Post Market Surveillance (PMS) documentation
• Test and Evaluation Reports
• General Safety and Performance Requirements (GSPR) documentation
• Clause Compliance Reports
• Provide regulatory support and guidance to internal and external stakeholders.
• Work closely with Regulatory Affairs, Quality, Design and other business functions to support product compliance activities.

About You

You will have experience working with Class I medical devices or higher and a solid understanding of EU MDR requirements. You will be highly organised, detail-focused and capable of managing multiple priorities effectively.

Essential Requirements

• Experience creating medical device technical files.
• Knowledge of EU MDR.
• Class I medical device experience or above.
• Good working knowledge of Microsoft Office.

Desirable Experience

• UK MDR 2002 knowledge.
• Clinical Evaluation, PMS, Risk Management or Usability Engineering experience.
• Knowledge of EU Machinery Directive, RoHS and REACH regulations.
• Experience working with British, European and international standards.

If you are looking for an opportunity to make a meaningful impact within a growing global medical device organisation, we'd love to hear from you.

Why You'll Love Working With Us

We’re not sharing the salary just yet, but it’s 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.

Here’s 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.