Head of Regulatory Affairs

The Company is in need of a Global Regulatory Head to join their team. The successful candidate will be tasked with the development and implementation of regulatory policies, procedures, and programs. This role requires a strategic thinker who can provide technical direction, ensure the achievement of regulatory aims, and maintain thorough and accurate records. The Global Regulatory Head will also be responsible for shaping market demands and regulatory constraints, monitoring project progress, and ensuring on-time project delivery through cross-functional collaboration. Applicants must have a degree in life science, with a higher degree being preferred, and at least 9-10 years' of experience in device and product development. An extensive understanding of combination product development and registration processes worldwide, including EU MDR standards, is essential. The role involves engaging with regulators, notified bodies, and trade associations, as well as participating in the integration of new acquisitions and due diligence analysis. The ideal candidate will have a proven track record of problem-solving, be adept at managing multiple tasks, and have a strong background in communication and team management. Active participation in business forums and scientific conferences to stay abreast of regulatory knowledge is also a key requirement.