Regulatory Operations Specialist
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About The Position
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. This role is part of the Medtronic Clinical & Regulatory Solutions (MCRS) organization, focusing on enhancing regulatory systems and processes. Key responsibilities include collaborating with the Registration and Listing Value Stream team to manage daily operations related to FDA Establishment Registrations, Device Listings, annual registration, and internal and external audits. This position also manages the Owner/Operator (O/O) account and provides guidance to Official Correspondents (OC), US Agents, and OU Regulatory teams. Additionally, there are opportunities to contribute to the Unique Device Identification (UDI) system and teams, ensuring data integrity within regulated systems like the Global Unique Device Identification Database (GUDID).
