Medical Device Senior Operations Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Office of Inspections and Investigations (OII)
FDA (Virtual), United States
Katelyn (Katie) Staub-Zamperini has worked for the FDA for 20 years and has held multiple positions within the Agency. Currently, Katie is a Senior Operations Officer with FDA’s Office of Medical Device and Radiological Health Inspectorate and serves as a technical and subject matter expert on inspections and the application of medical device and quality system regulations. She is also involved in OMDRHI’s implementation of QMSR. Prior to her current position, Katie worked as a Compliance Officer, leading, and managing numerous compliance cases and regulatory actions. She has also worked as a Medical Device Specialist Investigator, conducting many device inspections around the world, and covering a wide variety of facility and product types.
Friday, April 25, 2025
9:50 AM – 11:20 AM East Coast USA Time