Branch Chief, Division 3 Northeast, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
FDA
Joseph Strelnik has been a Branch Chief in the Office of Medical Device and Radiological Health Inspectorate (OMDRHI) within the Office of Inspections and Investigations (OII) supervising medical device Investigators and Specialists since 2022. Since beginning his FDA career in 2010, he has been physically located in the Indianapolis Resident Post where he served as an investigator trained in multiple programs/commodities including medical devices, food, tissue residue, shell eggs, bovine spongiform encephalopathy (BSE), and state contract auditing. Joseph became a Medical Device Specialist in 2015, leading several high-risk domestic and foreign inspections across various devices/radiological health products. Joseph’s work has provided the basis for numerous agency actions. He currently serves as a program subject matter expert on a variety of topics including training new and experienced device investigators, providing inspectional guidance, creation of the Remote Regulatory Assessment process, and spearheading artificial intelligence (AI) implementation efforts within the program. Joseph has a Bachelor of Science degree in Biomedical Engineering with a focus on Medical Device Innovation and is a Level II Certified Investigator.
Breakout #1: The Mechanics of an FDA Inspection
Thursday, April 23, 2026
10:30 AM - 12:30 PM East Coast USA Time