Jim Kleinedler, PhD, currently serves as Director of Regulatory Strategy at Medtronic since January 2023 and as an Expert Consultant at NDA Partners since June 2022. Prior to these roles, Jim acted as a Fellow in Regulatory Affairs at Boston Scientific from July 2014 to January 2023, where leadership was provided to the Emerging Therapy Team, focusing on regulatory, clinical, and reimbursement strategies across various growth sectors. Jim's earlier experience includes positions at the FDA from January 2012 to July 2014, encompassing responsibilities as a Biomedical Engineer overseeing cardiovascular device applications and biocompatibility review. Jim holds a Bachelor of Science in Chemical Engineering from Iowa State University and a PhD in Pharmacology, Toxicology, and Neuroscience from LSU Health Shreveport.
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