Join to apply for the Clinical Regulatory Lead role at BSI. Clinical Regulatory Lead - ACTIVE DEVICES Location: home based in UK, Spain, Germany, Ireland, Netherlands, Italy, France BSI is unable to provide relocation or visa sponsorship for this vacancy. Due to internal progression, we are looking for a Clinical Regulatory Lead with a specialization in ACTIVE MEDICAL DEVICES to join our Global Regulatory Compliance team. This role will focus on clinical regulatory support to operational teams and internal clinicians of BSI, requiring in-depth experience and knowledge of regulatory requirements for active medical devices. Responsibilities include monitoring competence throughout the clinical oversight process via internal auditing. Key duties: 1. Deliver and support audits of medical devices to maintain awareness of BSI’s systems and handle escalated queries. 2. Provide leadership and mentoring in medical device expertise for existing and new Global Schemes. 3. Advise and support Global Heads, Product Specialists, and Scheme Managers. 4. Assist the broader team and training lead in developing and delivering internal and external training materials on Medical Devices, ensuring knowledge of regulatory changes and amendments is current. Requirements: - Strong experience and knowledge of regulatory and compliance requirements of active medical devices. - Good understanding of Medical Devices Regulations, guidance, and standards. - Understanding of clinical evaluation processes, data analysis, and clinical study design. About BSI: BSI helps 80,000 clients worldwide improve their businesses, from business continuity to space exploration, embedding habits of excellence for better performance, risk management, and sustainable growth. Benefits include annual leave, bank holidays, learning & development opportunities, and flexible benefits tailored to your lifestyle. Our values: Client-centric, Agile, Collaborative. We aim to foster a sense of belonging by providing development opportunities within a global organization, all while having fun doing great work. This is a mid-senior level, full-time position. #J-18808-Ljbffr