About Jessica Mu

With 28 years of experience in the life sciences quality and compliance space (including over 20 years at the U.S. Food and Drug Administration and nearly a decade in industry), I’ve navigated the medical device product lifecycle from both sides of the fence. At Jessica Mu Consulting, LLC, I offer a boutique consulting model centered on direct, personalized access to FDA regulatory expertise. My mission is to guide manufacturers through complex regulatory landscapes, enabling them to achieve robust compliance and effectively mitigate risks, with a paramount focus on public health protection, leading to compliant pathways to market safe and effective products.

My Professional Journey & Expertise

My career journey has provided me with a comprehensive understanding of regulatory demands and industry challenges:

• Industry Foundation (1997-2002): I began my career in the life sciences industry, where I worked closely on a combination product premarket approval, implemented quality systems, executed process validations, and hosted FDA inspections. This foundational experience provided crucial insight into industry operations.

• Global Consulting (2006-2008): At a global consulting firm, I assisted drug and device companies in training on and implementing quality systems, and conducted internal and supplier audits, gaining broad exposure to diverse operational models.

• Extensive FDA Leadership, Investigations & Compliance Expertise (2002-2006, 2008-2025): My tenure at the FDA began as a Medical Device Investigator (2002). I then advanced to Compliance Officer (2009), handling diverse medical device, drugs, and dietary supplement cases. In 2019, I was promoted to Director of the Compliance Branch (Office of Medical Devices and Radiological Health, ORA). In late 2024, as part of FDA’s reorganization efforts, I subsequently served as Assistant Director, Establishment Assessment Team at CDRH, further deepening my insight into how the agency’s key elements intersect to achieve its mission and strategic priorities.

  • Key Contributions as Compliance Officer:

    • Processed and evaluated numerous firm responses to violative FDA 483 observations (and Establishment Inspection Reports) to determine cases for further agency action.

    • Drafted and issued numerous warning letters, untitled letters, and held regulatory meetings across medical device, drug, and dietary supplement manufacturers.

    • Led and coordinated multiple successful permanent injunction cases.

    • Provided strategic guidance and oversight to investigation teams on complex compliance issues and for-cause follow-up inspections.

  • Leadership Impact at FDA:

    • Led cross-functional teams of compliance officers and recall coordinators, making critical decisions on case elevation for FDA action or encouraging firm-initiated recalls.

    • Evaluated and authorized permanent injunction cases, numerous Warning Letters, Untitled Letters, Regulatory Meetings, and Warning-Letter close-outs.

    • Coordinated closely with the Investigations Branch on high-profile for-cause inspections, ensuring comprehensive data collection, critical evidence gathering, and coordinating enforcement strategies.

    • Mentored investigators and compliance officers, delivering formal training and on-the-job coaching.

    • Represented FDA workgroups that shaped key policy and procedures, including those focused on enhancing recall operations, establishing QMSR citations, reorganizing compliance functions, and serving as the subject matter expert for GAO audits.