Michael C. Rogers is Associate Commissioner for Regulatory Affairs (ACRA) in the FDA’s Office of Regulatory Affairs (ORA). In this role, he oversees inspections, compliance, enforcement, field laboratory operations, import operations, and strategic planning, among other areas for all FDA regulatory programs.
Throughout his FDA career, Mr. Rogers has led on numerous national and international investigations, public health related emergencies, as well as natural disaster recovery efforts.
Mr. Rogers served as Assistant Commissioner for Human and Animal Food Operations in ORA, focusing on inspections, investigations, and compliance-related issues to keep the American food supply safe. Previously, he was senior advisor for medical products, where he was responsible for critical regulatory issues and policies, setting strategic direction for new regulatory and technological developments to critical issues. He also provided strategic guidance related to domestic and foreign inspections.
Prior to his role as senior advisor, Mr. Rogers served as regional director in the FDA’s Latin America regional office, where he was stationed in Costa Rica. He was responsible for the FDA’s oversight of products produced in 44 countries and territories in Latin America and the Caribbean for the U.S. market, a region that was responsible for 30% of FDA-regulated imported products. Mr. Rogers also worked with foreign governments to develop international agreements.
Previously, Mr. Rogers served as a deputy director in ORA’s Office of Regional Operations, where he directed all field activities, and director of ORA’s Division of Field Investigations.
Mr. Rogers began his FDA career based in the Baltimore District Office’s Northern Virginia resident post, as an investigator, and was later promoted to a supervisory investigator, where he managed investigators who were responsible for regulatory oversight in Virginia, parts of Maryland, Washington, D.C., and West Virginia. He also conducted domestic and international inspections as an investigator and as a supervisor. Mr. Rogers has experience inspecting high-profile clinical trials, animal testing facilities, pharmaceutical companies, food facilities and large blood banks.
Mr. Rogers received a bachelor’s degree in Zoology and Chemistry from North Carolina State University, and a master’s degree in management from the University of Maryland University College.