Jim Kleinedler

Director, Regulatory Strategy

Jim Kleinedler is the Director of Regulatory Strategy in Medtronic’s Global Regulatory team. Jim is a former FDA device reviewer with deep expertise in developing clinical and commercial pathways for devices in strategic new spaces. Jim joined Medtronic from Boston Scientific, where he founded and led BSC’s Emerging Therapy Team, an internal consulting team that provided regulatory, clinical, and reimbursement strategies to help build business cases and prioritize pipeline investment. In addition to supporting opportunity assessments, Jim developed and executed Class II/III regulatory filings for BSC’s Interventional Cardiology business, with emphasis on premarket activity and human feasibility studies. Jim’s background includes degrees in Chemical Engineering and Toxicology, including expertise in evaluation of chemical characterization and toxicological risk assessments. He is the author on 10 peer-reviewed publications and inventor on seven patents related to medical devices.

Talks About
#medicaldevices #regulatoryaffairs

Preferred Locations
#UnitedStates