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Senior Regulatory Affairs Specialist
Job Summary: The Senior Specialist, Regulatory Affairs is responsible for preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities. Essential Functions: Supports in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals. Represent regulatory affairs on project/product teams, risk management, and all design review meetings. Working with department management provides regulatory guid
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