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Edwin Ramos

    Edwin Ramos is currently the Director of Compliance of the OHAFO D4E. Mr. Ramos’ career has spanned a variety of regulatory work, i.e., regulatory laboratory, regulatory review science, and regulatory compliance.

    Mr. Ramos started his career working as an analytical chemist in Texas A&M University, Office of the Texas State Chemist. He joined Center for Drug Evaluation and Research in 1990 as a chemistry reviewer in the Office of Generic Drugs, where he worked for 13 years. He later moved to the Office of Regulatory Affairs (ORA) Dallas District Office to work as a Compliance Officer, where he had oversight responsibility for Rx/OTC/dietary supplements compliance programs.

    In 2009, Ramos moved to the ORA San Juan District Office and became the Director of Compliance (DCB) with responsibility of the domestic and imports compliance areas. As DCB, he has monitored various regulatory commodity programs as well as supervised staff who specialized and performed work in all commodities under FDA jurisdiction. He processed cases in all program areas including drugs, dietary supplements, foods, medical devices, imports and MQSA.

    Since Program Alignment, Edwin have been instrumental in directing the development and implementation of regulatory compliance practices and in communicating to external stakeholders important information about newly-implemented FSMA regulatory requirements. Overall, Edwin has spent the last 17 years of his career in ORA.