(IIZ64) | CHIEF MEDICAL DEVICE REGULATOR

Bebeeregulatory


Regulatory Compliance Manager Role This is a mid-senior level, full-time position within our Regulatory Affairs team. Main Responsibilities: 1. Deliver and support audits of medical devices to maintain awareness of regulatory systems and handle escalated queries. 2. Provide leadership and mentoring in medical device expertise for existing and new regulatory schemes. 3. Advise and support senior managers, specialists, and scheme leaders. 4. Assist the broader team 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 requirements of active medical devices. - Fundamental understanding of regulations, guidance, and standards. - Understanding of clinical evaluation processes, data analysis, and clinical study design.

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