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 Were looking for a Regulatory Affairs Specialist to join our team. In this role, youll ensure our medical devices meet UK, EU, and international regulatory standards, with fully compliant technical documentation. Youll 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 Youll 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 youre passionate about making a difference in healthcare and thrive in a collaborative, fast-paced environment, wed love to hear from you. Why You'll 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 recognisednot 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. 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-224 331
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