Carol Cave is the Acting Associate Commissioner for Regulatory Affairs (ACRA) in the FDA’s Office of Regulatory Affairs (ORA). In this role, she oversees approximately 5,000 ORA staff stationed in the U.S. and around the world.
Before becoming Acting ACRA, Ms. Cave served as the Deputy Associate Commissioner for Regulatory Affairs (DACRA), overseeing inspections, compliance, enforcement, field laboratory operations, import operations, and strategic planning, among other areas.
Prior to serving as DACRA, she was Assistant Commissioner of Import Operations, leading the ORA’s Office of Enforcement and Import Operations (now the Office of Import Operations). In this role, she oversaw FDA-regulated imported products across all commodities, including investigations and compliance activities to ensure products entering the U.S. market complied with U.S. laws. Ms. Cave also served as the FDA lead for coordinating agency import activities with U.S. Customs and Border Protection, including developing and implementing joint regulations, policies, procedures, and operations, and coordinated with other federal agencies and foreign governments with border responsibilities.
Before joining the FDA, Ms. Cave was deputy director of the Office of Compliance and Field Operations at the U.S. Consumer Product Safety Commission (CPSC), where she partnered with other federal government agencies to develop unique approaches and solutions to identify potentially defective consumer products.
Ms. Cave served in several leadership roles at CPSC, including as an assistant executive director in the Office of Import Surveillance, where she led the agency’s nationwide compliance and enforcement investigations program, involving firms and individuals importing consumer products into the U.S. In this role, she created and built a web-based system to identify, evaluate, and mitigate risks of dangerous products at the ports of entry. She also served as the associate executive director of field operations, where she was responsible for nationwide consumer product safety investigations to enforce U.S. Laws and support public awareness and compliance on consumer safety.
Ms. Cave also served in other capacities during her tenure at CPSC, including as a director of state and local programs in the Directorate for Field Operations, and as a compliance officer in the Office of Compliance’s Special Investigations Unit.
Ms. Cave received a bachelor’s degree in Consumer Economics from the University of Maryland.