Regulatory Affairs Specialist

Regulatory Affairs Specialist

Who We Are at Drive DeVilbiss

Drive DeVilbiss 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 Healthcare Solutions that Enhance Lives”
 
We’re looking for a Regulatory Affairs Specialist to join our team. In this role, you’ll ensure our medical devices meet UK, EU, and international regulatory standards, with fully compliant technical documentation. You’ll work closely with cross-functional teams including design, quality, and other regulatory professionals, taking ownership of your workload and driving continuous improvement.
 
Key Responsibilities:

Create and review technical files in line with EU MDR and other global regulations
Develop supporting documentation including risk management, usability, and clinical evaluation reports
Provide expert regulatory support to internal and external stakeholders
Maintain high standards of confidentiality and departmental organisation
 
What You’ll Bring:

Experience with Class I or higher medical devices
Strong knowledge of EU MDR and technical file creation
Excellent attention to detail, communication, and time management skills
A proactive, solution-focused mindset
 
Desirable:

Familiarity with UK MDR 2002, EU Machinery Directive, RoHS, REACH
Experience with post-market surveillance and usability engineering
 
If you’re passionate about making a difference in healthcare and thrive in a collaborative, fast-paced environment, 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 recognised—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.
 
Equal Opportunities Statement:

At Drive DeVilbiss, 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.
 
REF-(Apply online only)