Elexis Padgett
Biomedical Engineer/ Lead Reviewer @ FDA | Device Regulation, Project Management
- Role
- Biomedical Engineer Lead Reviewer at FDA
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
Experience
Biomedical Engineer Lead Reviewer
Mar 2024 — Present
Reviewed regulatory submissions for cardiovascular devices, ensuring compliance with 21 CFR 820 and ISO/AAMI/ANSI standards.• Managed projects with subject matter experts and medical professionals to assess safety and effectiveness of medical devices.• Collaborated with team lead and director to develop regulatory strategies and understand total product lifecycle.Handled 510(k) submission, Q-Submissions, De Novo, Expedited Entry Breakthrough Requests, PMA/IDE Reports and Supplements, Recalls and experienced with MAUDE database. Device Area: Guidewires, Catheters, Coronary Stents, Drug-Eluting Stents, Scoring/Cutting Balloon Catheters, TAVR catheters, and PTCA catheters
Education
City University of New York City College
Master of Science - MS
2017 — 2022
Rensselaer Polytechnic Institute
Bachelor of Science (B.S.)
2009 — 2013
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