Regulatory Affairs Specialist -Med Devices

Role - QA/RA Senior Specialist Location - London Hours 40 hours Monday to Friday Salary £50,000 to £60,000 Overview We are seeking a highly skilled QA/RA Senior Specialist to join our clients team. To succeed in this role, you will bring extensive experience in Quality Assurance and Regulatory Affairs within the Medical Device industry, with a strong command of ISO 13485, regulatory compliance, and post-market requirements. You will play a key role in maintaining and improving our Quality Management System (QMS), guiding internal and external audits, and ensuring our products meet applicable regulatory standards throughout their lifecycle. Key Responsibilities Develop, implement, and maintain Quality and Regulatory processes in line with applicable regulations and standards (e.g., ISO 13485, MDR). Drive continuous improvement initiatives within the QMS. Collaborate cross-functionally and with the external subcontractors to ensure ongoing regulatory compliance. Provide QA/RA support during changes and product lifecycle management. Lead risk management activities and oversee post-market surveillance processes. Conduct thorough root cause investigations and manage Corrective and Preventive Actions (CAPA). Coordinate the preparation and maintenance of technical and regulatory documentation. Develop, maintain, and execute internal and external audit plans to ensure audit readiness and compliance. Author, review, and update QMS policies, procedures, and work instructions. ..... full job details .....