Regulatory Affairs Specialist II (Orthopedics PWT AES) - Medical Device Business Services, Inc.
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About The Position
Medical Device Business Services, part of Johnson & Johnson MedTech, is recruiting for a Regulatory Affairs Specialist II to support the Digital PWT AES regulatory affairs organization. The preferred location for this role is within a commutable distance of Palm Beach Gardens, FL however candidates located near Raynham, MA, West Chester, PA, and Warsaw, IN will also be considered. This role will work a Flex/Hybrid schedule with 3 days per week in office, there is NO remote option. The Regulatory Affairs Specialist II provides regulatory guidance to project teams in business planning and related submissions to support DePuy Synthes Digital PWT AES products. Under minimal direction, the individual develops and performs regulatory strategies for significant change supplements and 510(k) registrations to support the continued commercialization of products in key countries. This role helps define the data and information needed for regulatory actions in conjunction with cross-functional teams. In addition, this candidate guides conformance with applicable regulations through the development of standard methodologies for Regulatory Affairs processes, procedures and systems.
