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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 and clinical


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