Jonathan Helfgott, MS
Senior FDA regulatory and clinical strategist with 20+ years of experience guiding medical products and technologies through high-stakes regulatory decision points.
Jonathan Helfgott brings deep expertise in FDA regulatory strategy, clinical development planning, and market access across medical devices, digital health, diagnostics, and biopharma. He has advised organizations on complex FDA pathways, evidence generation, and strategic Agency engagement; particularly for emerging and novel technologies where precedent is limited and regulatory decisions carry material risk.
Areas of Focus / Expertise
- FDA regulatory pathway and classification strategy
- FDA meeting strategy and briefing package development
- Premarket submissions (e.g., 510(k), De Novo, IDE/IND)
- Clinical evidence strategy, endpoints, and totality-of-evidence frameworks
- Health authority communications and global regulatory submissions
- Clinical trial design and execution
- U.S. market entry strategy for international companies
Selected Experience & Impact
Over the course of his career, Jonathan has supported programs resulting in successful regulatory authorizations and streamlined development pathways, working across early product development through post-market commercialization. He has held senior FDA roles including Associate Director for Risk Science and has led global regulatory affairs in industry.
Background & Credentials
Prior to founding FDA Partners and serving as Program Coordinator and Senior Lecturer for the MS in Regulatory Science at Johns Hopkins University, Jonathan held key leadership roles at the U.S. Food and Drug Administration in both the Center for Drug Evaluation & Research and the Center for Devices and Radiological Health. He holds an MS in Bioscience Regulatory Affairs from Johns Hopkins University and a BS in Cell/Molecular Biology & Genetics from the University of Maryland.
Jonathan is actively engaged in regulatory education and professional communities, serving in leadership roles such as President of the Association of Graduate Regulatory Educators.