Jake Baldauf
Medical Devices | Regulatory Affairs | New Product Development | MBA Candidate
- Role
- Principal Regulatory Affairs Specialist at Boston Scientific
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
Experience
Principal Regulatory Affairs Specialist
Aug 2021 — Present
Interventional Oncology - Peripheral Interventions New Therapy Accelerator leader for Y-90 Glioblastoma FIH EFS IDE program Arterial - Peripheral Interventions Manages, executes, and owns the global regulatory strategy and US submission for a drug-eluting stent new product development program. Provides strategic direction and support for EU MDR, PMDA Shonin, and NMPA registration. Extensive US Class experience including demonstrated success with: Combination Products, Modular PMA, PMA/s, IDE/s, Breakthrough Device, Q-submissions, Clinical Trials, Compassionate Use, and CfQ streamlined Original PMA manufacturing section.
Education
The University of Kansas School of Business
Master of Business Administration - MBA
2022 — 2024
St. Cloud State University
Master’s Degree, Regulatory Affairs and Services - Medical Device
2014 — 2017
University of Wisconsin-Eau Claire
Bachelor of Science (B.S.), Chemistry with Business Emphasis
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