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
Regulatory Affairs Manager employer: Drive DeVillbiss Healthcare UK
At Drive Medical, we pride ourselves on being a leading employer in the medical manufacturing sector, offering a supportive and inclusive work culture that values employee contributions. Our commitment to professional growth is evident through our comprehensive benefits package, including generous annual leave, a robust pension scheme, and access to an Employee Assistance Programme, all designed to enhance your work-life balance. Join us in a role where you can make a meaningful impact while enjoying perks like free onsite parking and long service recognition, all within a dynamic environment dedicated to innovation and excellence.
Contact Details:
Drive DeVillbiss Healthcare UK Recruitment Team
