Upuli Strauss
Strategic Regulatory Affairs Specialist | Cross-Functional Team Management | Global Compliance & Market Strategy | Project Management | STEM Mentor
- Role
- Principal Regulatory Affairs Specialist Crm at Medtronic
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
About Upuli Strauss
Strategic and results-driven Principal Regulatory Affairs Specialist with 7+ years of experience guiding Class medical devices from concept to global market launch. Proven record of leading regulatory strategies that secure early FDA approvals—including the second Real-World Evidence (RWE)-based approval in the industry for Japan—and successfully navigating complex submissions under EU MDR 2017/745. Adept at authoring technical documentation, managing cross-functional teams, and aligning with Notified Body expectations to maintain uninterrupted market access. Experienced in post-market compliance, change management, and mentoring emerging regulatory talent. Seeking to leverage this blend of global regulatory expertise, program leadership, and process optimization to drive and lead market success in a dynamic healthcare technology environment.
Experience
Principal Regulatory Affairs Specialist Crm
Jul 2024 — Present · Mounds View, MN, US
Education
University of Minnesota
Bachelor’s Degree, Biology, Society, and Environment (BSE)
St. Cloud State University
Master of Science - MS, Regulatory Affairs and Services
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