Mike Ryan

Regulatory Affairs Practice – U.S.

BACKGROUND

FOCUS AREAS

AWARDS & HONORS

A seasoned regulatory leader with 21+ years at FDA, known for strategic problem solving, collaborative leadership, and bringing clarity to regulatory complexity.

• FDA medical device premarket submissions (e.g., 510(k)s, De Novos, PMAs)
• Strategic planning & execution
• FDA regulation of digital health
• FDA regulatory policy
• FDA adverse event reporting (Medical Device Reporting)
• FDA quality & compliance
• Change management

Recipient of numerous individual and group FDA and CDRH awards for exceptional work and regulatory innovations, including the FDA’s highest individual honor award, the Award of Merit.

Mike Ryan brings a rare combination of regulatory depth and strategic vision to his role as Executive Vice President. With over 21 years of experience at the U.S. Food and Drug Administration, Mike has worked across the full regulatory spectrum – premarket review, compliance, postmarket surveillance, and policy development – giving him a truly comprehensive view of the medical device landscape.

During his tenure at FDA, Mike served as a lead premarket reviewer and a Total Product Life Cycle (TPLC) manager across multiple product areas. He played a central role in modernizing regulatory processes as a regulatory advisor and senior leader in CDRH. His contributions include reviewing and overseeing hundreds of premarket submissions, developing dozens of regulations and guidance documents, and leading continuous improvement and transformative initiatives in compliance and postmarket surveillance.

Mike is widely recognized for his collaborative approach, clear communication, and ability to navigate complex regulatory and organizational challenges. He excels at strategic problem solving and is especially passionate about advancing innovative medical products that address areas of unmet need, ensuring patients benefit from the best science and technology have to offer.