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Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA

Sr. Director, Reg. Affairs
QuidelOrtho

Frank Pokrop has worked in both the drug and medical device industries and has obtained this unique set certifications: CSQE, CISA, CPGP and RAC. Frank is a senior director of regulatory affairs at QuidelOrtho where he leads the implementation of the IVDR regulation and manages post market functions.

His background includes worldwide submissions and product approvals, recall management, leading global compliance and auditing programs, product launches, vigilance reporting, and he has worked in manufacturing. Frank has taught at UC San Diego: (1) Medical device submissions, and, (2) Overview of medical device regulatory affairs. He also served as a voting memebr on the IRB at UCSD for 4 years.

He is a member of the Board of Directors for RAPS. He is currently a member of the FDA Committee on Hematology products. He volunteered at the San Diego Regulatory Affairs Network (SDRAN) for 10 years serving including VP of programs and President, and he lives in Carlsbad with his wife and a female chocolate Labrador.

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