Job Title

Regulatory Affairs Manager – Medical DevicesNorth Yorkshire | Hybrid Working (2–3 days WFH) Are you ready to step into a Regulatory Affairs leadership role where you can genuinely shape strategy, lead people, and work with a super supportive, collaborative team?We’re looking for an experienced Regulatory Affairs Manager to take ownership of regulatory strategy, registrations, and compliance across a diverse medical device portfolio, while leading and developing a growing RA team. The RoleReporting into the Head of Regulatory Affairs, you’ll be responsible for the end-to-end regulatory lifecycle of medical devices across the UK, EU, US and ROW markets. This is a hands-on leadership role, blending people management, strategic planning, and technical regulatory expertise.You’ll oversee regulatory submissions, certifications, and change notifications, while ensuring compliance with evolving global regulations including MDR, IVDR and UKCA. Key ResponsibilitiesLead, mentor and develop a Regulatory Affairs team (direct and indirect reports)Own regulatory strategy for existing products and new device introductionsManage and maintain CE, UKCA, FDA (510k) and ROW registrationsOversee technical files, regulatory dossiers and conformity assessmentsAct as a key regulatory partner to R&D, Quality, Clinical, Marketing and SalesTrack regulatory change controls, submissions and approvals to deadlinesMaintain internal and external regulatory databases (e.g. MHRA)Act as a key point of contact with regulatory authorities and notified bodiesSupport audits, PMS activities, UDI compliance and labelling approvalsDrive continuous improvement in regulatory processes and systemsAbout YouYou’ll be an experienced medical device regulatory professional who enjoys leading teams and navigating complex regulatory landscapes. Essential experience:Strong regulatory experience within medical devices (ideally 5+ years)Working knowledge of MDR, IVDR, UK MDR, ISO 13485Hands-on experience with EU technical files (Class I–III)Experience with change notifications and regulatory authority interactionsProven people management and project management capabilityDesirable experience:FDA 510(k) submissionsROW registrationsUK Responsible Person / EU Importer knowledgeAudit participation and QMS experienceClinical evaluation, PMS or PMCF exposureWhy Apply?Strategic leadership role with real influenceHybrid working: 2–3 days from home each weekCollaborative, cross-functional working environment. Everyone is very supportive and they foster a great working environment/culture.