The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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Manager or Director, Regulatory Affairs, Medical Devices
Manager or Director of Regulatory Affairs, Medical Devices, is responsible for leading various operational aspects of Medical Device Regulatory Affairs objectives for assigned devices and device/drug products, life cycle management initiatives and global regulatory strategy, regulatory submissions, and interaction with US and foreign regulatory authorities. Key Responsibilities Include: Responsible for developing and executing regulatory plans for assigned medical device programs. Develops technical content, format, and accountability for regulatory submissions and related supplements and amendments. Advises project teams regarding the development and implementation of regulatory strategy through the analytic, GMP an
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