Jessica Mu is a regulatory professional with over 25 years of experience at the U.S. Food and Drug Administration (FDA) and FDA-regulated industries. Her experience includes enforcement strategy, post-market oversight, and quality systems, with a specific focus on the medical device and pharmaceutical sectors. A non-lawyer, Jessica advises clients on inspection readiness, quality system compliance strategy, and remediation efforts. She works closely with companies to help them respond to FDA inspectional observations and Warning Letters, and conducts “mock” audits for firms as they prepare for FDA inspection.
Before joining Covington, Jessica served in leadership roles at FDA’s Center for Devices and Radiological Health (CDRH) and the Office of Medical Device and Radiological Health Inspectorate (OMDRHI). As Acting Division Director of Global Operations at OMDRHI, she led teams overseeing recall operations, international inspections, and senior operations programs. She also served as Assistant Director within CDRH, continuing her leadership in compliance oversight.
Prior to these roles, Jessica was Director of the Compliance Branch in FDA’s Office of Medical Device and Radiological Health Operations, where she managed a team of compliance officers and recall coordinators responsible for regulatory, compliance, and recall activities across the western United States. In this role, she reviewed and cleared all compliance activities, including advisory (i.e., warning letters, untitled letters) and enforcement actions (i.e., injunctions). Jessica also evaluated and oversaw firm response reviews to compliance actions and FDA-483 observations.
Back
