Regulatory Affairs Specialist

Cure Talent are delighted to be partnered with an established medical device manufacturer with a long-standing portfolio of Class I and Class IIa medical devices supplied across the UK and European markets. Due to continued growth, they are now looking to appoint a Regulatory Affairs Specialist to join their Quality and Regulatory team based in Bromsgrove. As the new Regulatory Affairs Specialist, you will play a key role in ensuring ongoing compliance with UK MDR and EU MDR requirements, supporting products throughout the full lifecycle from development through to post-market activities. Working closely with the QA Manager, you will be responsible for maintaining technical documentation, supporting regulatory submissions, liaising with regulatory bodies, and contributing to the continued development of the Quality Management System. To be successful as the new Regulatory Affairs Specialist, you will have experience working within Regulatory Affairs in the medical device industry, with a strong understanding of UK MDR, EU MDR, UKCA and ISO 13485. You will have hands-on experience preparing technical documentation and supporting regulatory compliance activities within a regulated environment. Key Responsibilities Support the implementation and continual improvement of the Quality Management System in line with ISO 13485 Prepare, review and maintain Technical Files, Design Dossiers and GSPR checklists in accordance with UK MDR and EU MDR requirements Support the preparation ..... full job details .....