Gloucester
Overview We are seeking an experienced and strategic Head of QA/RA to lead and develop our clients Quality and Regulatory function within a growing medical device organisation. This is a critical leadership role responsible for ensuring compliance with global regulatory requirements, driving quality excellence, and supporting the business through product development and commercialisation. The successful candidate will play a key role in shaping and maintaining a robust Quality Management System (QMS), ensuring alignment with ISO 13485 and EU MDR, while building and mentoring a high-performing QA/RA team. Key Responsibilities Quality & Compliance Leadership • Lead the development, implementation, and continuous improvement of the company’s Quality Management System (QMS) in line with ISO 13485 and applicable regulatory requirements., • Ensure ongoing compliance with EU MDR (2017/745) and other global regulatory frameworks., • Act as the primary Quality and Regulatory representative for internal and external stakeholders. Regulatory Affairs • Oversee regulatory strategy, submissions, and approvals for medical devices across key markets., • Ensure timely and accurate regulatory filings and maintenance of technical documentation., • Maintain awareness of evolving regulatory requirements and implement necessary changes. Audit & Inspection Readiness • Lead internal and external audits, including notified body and regulatory authority inspections., • Maintain audit readiness at all times., • Serve as Lead Auditor, conducting internal audits and overseeing audit programmes. Team Leadership & Development • Build, lead, and develop a high-performing QA/RA function., • Recruit, mentor, and retain talent within the quality and regulatory team., • Foster a strong quality culture across the business. Cross-Functional Collaboration • Partner with R&D, Manufacturing, and Commercial teams to ensure quality and regulatory considerations are embedded throughout the product lifecycle., • Provide strategic input to senior leadership on quality and regulatory matters. Requirements Experience & Qualifications • Proven experience in a senior QA/RA leadership role within the medical device industry., • Strong working knowledge of:, • ISO 13485, • EU MDR (2017/745), • Demonstrated experience building and managing a QMS., • Track record of hiring and developing QA/RA teams., • Certified Lead Auditor (ISO 13485 or equivalent) essential., • Experience leading audits with notified bodies and regulatory authorities.