Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist at Medtronic develops innovative strategies for regulatory approval and ensures compliance with global medical device regulations, including FDA eSTAR submissions and EU MDR requirements. The role involves collaborating with cross-functional teams, managing product submissions, and providing strategic leadership to support the approval and market release of software-based medical devices. The position requires a deep understanding of IEC 62304, software lifecycle processes, and international regulatory standards to drive successful product launches and maintain compliance.