Michelle Mirzaee
Senior Regulatory Affairs Specialist, TMVR at Edwards Lifesciences
- Role
- Senior Regulatory Affairs Specialist, Tmvr at Edwards Lifesciences
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Michelle Mirzaee
Regulatory affairs professional with global experience across Class medical devices, including cardiovascular, neurovascular, and critical care technologies. My work focuses on translating complex regulatory frameworks into strategic pathways that enable product development, global market access, and portfolio continuity.I bring a thoughtful, problem-solving approach to regulatory strategy and partner closely with R&D, clinical, quality, manufacturing, and commercial teams to align regulatory decisions with broader business objectives. Known for connecting regulatory context with forward-looking strategy, I help teams navigate evolving global requirements while supporting innovation and timely patient access.Currently supporting regulatory strategy for next-generation Transcatheter Mitral Valve Replacement (TMVR) therapies.
Experience
Senior Regulatory Affairs Specialist, Tmvr
Feb 2026 — Present · Irvine, CA, US
Transcatheter Mitral Valve Replacement (TMVR) • Lead regulatory strategy execution for TMVR new product development programs (M3, Innovalve), partnering with R&D and cross‑functional leaders to advance global clinical development and commercialization.
Education
University of California, Davis
Bachelor of Science - BS, Anthropology
2013
UC Irvine
Certificate, Regulatory Affairs and Compliance (Medical Device Track)
2017
University of California, Davis - Graduate School of Management
Master of Business Administration - MBA
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