Compliance Officer in Establishment Assessment Team 3, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA
Jeff Wooley, Compliance Officer, FDA CDRH, has served with the Food and Drug Administration since 2005, where he has held progressively responsible positions in compliance, regulatory operations, and enforcement. He served as an Investigator conducting primarily medical device and drug inspections domestically and internationally. Currently serving as Acting Assistant Director, he leads a compliance team and provides strategic oversight of complex regulatory operations including case workflows, MDSAP audit evaluations, recall coordination, and corrective action implementation across multiple device product categories.
Jeff is a subject matter expert in medical device compliance and quality systems. He has successfully processed numerous high-stakes cases across medical devices and drugs. His work has included numerous warning letters, untitled letters, regulatory meetings, recalls, and judicial actions. He provides authoritative guidance on complex regulatory matters and mentors investigative personnel on Federal Food, Drug, and Cosmetic Act interpretation and policy implementation.
Jeff is an has designed and delivered comprehensive training programs including National Basic New Hire and National Basic Device courses. He has presented at numerous industry conferences and currently serves on the Basic Medical Device Course Advisory Group.
Friday, April 24, 2026
10:00 AM - 12:00 PM East Coast USA Time