[XI184] | HEAD OF NURSING

Bsi


Clinical Regulatory Lead Role This is a mid-senior level, full-time position within our Global Regulatory Compliance team. Key Responsibilities: 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.

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