Melinda Plaisier is Associate Commissioner for Regulatory Affairs at the Food and Drug Administration. She has responsibility for over 4,000 staff and operations in the Office of Regulatory Affairs (ORA), Global Regulatory Operations and Policy. ORA has responsibility for imports, inspections and investigations, compliance and enforcement, and field laboratory operations.
ORA supports FDA’s product centers by inspecting regulated products and manufacturers, analyzing samples of regulated products, reviewing imported products offered for entry into the United States, and responding to public health emergencies. ORA also works with other Federal, State, Local, Tribal and Territorial, as well as foreign regulatory counterparts to further FDA’s mission.
Mrs. Plaisier began her career in public policy, working in the U.S. Congress for over a decade. She joined FDA in 1995, spending more than 13 years in the Office of the Commissioner, where she served as the Associate Commissioner for Legislation, providing executive leadership in directing and managing the agency’s congressional relations and legislative activities. She also served as the Associate Commissioner for International Programs, where she focused on negotiating international agreements and working with developing nations.
Prior to becoming Associate Commissioner for Regulatory Affairs, she served as the Regional Food and Drug Director (RFDD) for the Central Region. As the RFDD, she provided executive leadership in directing and managing the programs of FDA within the 15 states of the Central Region. Throughout her tenure in government she has been recognized for her leadership and management contributions with numerous agency honor awards, including FDA’s highest award, the Award of Merit. In 2004 and again in 2009, Mrs. Plaisier was awarded the Presidential Meritorious Rank Award for exceptional long-term accomplishments in the Senior Executive Service.