Regulatory Affairs Associate

Regulatory Affairs AssociateOffice-based (with some flexibility) Occasional national and international travel Salary: £42,000 -£44,000 Location; GloucesterWe are looking for a detail-driven and motivated Regulatory Affairs Associate to join a growing and dynamic team within the medical devices sector. This is a fantastic opportunity to play a key role in ensuring regulatory compliance across international markets, supporting the development of life-changing products while working in a highly collaborative, quality-focused environment.The RoleReporting into the Regulatory Affairs function, you will play a key role in maintaining compliance with international medical device regulations and supporting the creation and maintenance of technical documentation.Key Responsibilities Support the preparation and maintenance of MDR Technical Documentation (Annex II and III)Assist with Class IIa conformity assessments and Notified Body interactionsSupport UK and international regulatory registrations including MHRA, FDA, Canada, and AustraliaMaintain regulatory documentation in line with ISO 13485 and ISO 14971 requirementsSupport post-market surveillance, vigilance, and PMCF activitiesReview labelling, IFUs, and promotional materials for regulatory complianceWork cross-functionally with Quality, Engineering, Manufacturing, and Commercial teamsSupport internal, customer, and external auditsAssist with UDI management, EUDAMED registrations, and regulatory change activities About You ..... full job details .....