Mary Hole

Branch Chief, San Jose Resident Post , U.S. Food and Drug Administration (FDA)

Mary Hole is a Branch Chief with the U.S. Food and Drug Administration (FDA), where she oversees the San Jose Resident Post and leads a team of medical device investigators based in the San Jose Resident Post and Alameda District Office.

Before joining the FDA in 2010, Mary spent more than 20 years in the pharmaceutical industry, first as a chemist and later as a Regulatory Compliance Manager. She also established a consulting business focused primarily on Drug Enforcement Administration (DEA) regulatory compliance for controlled substances. At the FDA, Mary began as an Investigator conducting medical device inspections, became a Supervisor in 2016, and was appointed Branch Chief in 2023. The San Jose Resident Post includes investigators across multiple commodities, including Foods, Pharma, BIMO, Medical Devices, and Import Operations. Mary holds a bachelor’s degree in biology from San Jose State University and an MBA.

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