Former FDA Director of Compliance Branch @ORA/OII | Former Assistant Director of Establishment Assessment Team @CDRH | Former FDA Medical Device Investigator
About me, 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 in Investigations, Compliance Officer, and Compliance Director roles, and nearly a decade in industry, I’ve navigated the medical device product lifecycle from both sides of the fence.
In April 2025, I retired from the FDA and launched Jessica Mu Consulting, LLC. As a boutique consulting firm, my goal is delivering highly personalized and strategic guidance. I believe that effective compliance is founded not just on meeting regulations, but on establishing sustainable, systemic Quality Systems that foster a culture of robust quality and support innovation.
This focused approach ensures you work directly with me, leveraging my inside knowledge to provide pragmatic, actionable strategies tailored precisely to your unique needs. While I maintain strong connections within the industry to strategically collaborate on larger, specialized projects when appropriate, my commitment is always to provide direct, high-level expertise with public safety at the forefront.
Comprehensive Regulatory & Compliance Service
Jessica Mu Consulting, LLC offers a wide spectrum of expert regulatory and compliance services designed to guide medical device and pharmaceutical manufacturers through their most critical challenges. My boutique model ensures you receive direct, personalized attention and strategies aligned with your specific needs; approaches are built on years of FDA insight, ensuring pragmatic solutions to achieve compliance.
- Compliance Assessment
- Mock FDA Inspections & Coaching
- FDA Inspection Support
- FDA 483 Response Strategy
- Warning Letter | Untitled Letter Responses
- Regulatory Meeting Preparation & Guidance
- FDA Recall Guidance