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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 position is part of the Medtronic Clinical & Regulatory Solutions (MCRS) organization, supporting regulatory systems and processes. You will be a recognized specialist in FDA Device Listing and Establishment Registrations. Primary responsibilities include supporting our Establishment Registration and Device Listing Value Stream team with day-to-day updates, annual registration and device listing reviews, audit support, provide consulting to our Operating Unit Regulatory Affairs teams and supporting ongoing projects. There are opportunities to also support our Unique Device Identification (UDI) system and teams to ensure data integrity in our regulated systems such as the Global Unique Device Identification Database (GUDID). Duties may include data entry, data cleansing, submitting expense reports related to FDA Establishment Registration, supporting our Regulatory Affairs teams within the Operating Units and supporting audits and inspections.
