Skip to main content
2026 MedCon Main banner

Michelle Glembin

Medical Device Senior Operations Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Office of Inspections and Investigations (OII)
FDA

Michelle Glembin serves as a Medical Device Senior Operations Officer within the Office of Medical Devices and Radiological Health Inspectorate (OMDRHI), Global Operations, part of the Food and Drug Administration's (FDA) Office of Inspections and Investigations (OII).

Ms. Glembin joined FDA in 2008 as an Investigator/Consumer Safety Officer at the Milwaukee, WI Resident Post. As a Certified Medical Device Investigator through FDA's certification program, she has conducted numerous domestic and international inspections across medical devices, bioresearch monitoring, and biologics. Throughout her FDA career, she has trained investigators, contributed to key policy workgroups—including the QMSR Implementation workgroup, Compliance Program workgroup, and IOM Workgroup—and completed multiple details within the former Office of Regulatory Affairs (ORA) and the Center for Devices and Radiological Health (CDRH).

Prior to joining FDA, Ms. Glembin spent 18 years in industry, serving as Director of Regulatory & Quality.

Ms. Glembin holds a Bachelor of Science degree in Biology with an emphasis in Microbiology from St. Cloud State University in St. Cloud, Minnesota.

Presentation(s):