Jonathan Helfgott
Leading FDA Partners advisory firm with 20+ years in the device, diagnostic, and combination product industry. Former Senior FDA Official and current Senior Lecturer for Johns Hopkins University MS in Regulatory Science.
- Role
- Regulatory Strategist at Synex
- Location
- Rockville, MD, US
- LinkedIn followers
- 500 followers
About Jonathan Helfgott
With over 20 years of experience, I specialize in translating FDA complexity into innovation pathways. My expertise spans the development of regulatory, clinical, GxP, and market access strategies, enabling successful FDA pre-market submissions, site inspections, and approvals across diverse therapeutic areas, including Neurology, Cardiology, Oncology, Endocrinology, Infectious Diseases, Orthopedics, Surgery, Radiology/Imaging, Diagnostics, and Combination Products.As an industry, academic, and former FDA senior leader, I have advanced the integration and adoption of cutting-edge solutions such as AI/ML-based technologies, Digital Health, Software as/in a Medical Device (SaMD/SiMD), eClinical tools, and utilization of Real-World Data/Evidence (RWD/RWE).I am passionate about driving innovation while ensuring FDA success across the entire product lifecycle.
Experience
Regulatory Strategist
Jan 2025 — Present · Toronto, ON, CA
Education
The Johns Hopkins University
Master of Science - MS, Bioscience Regulatory Affairs
2005 — 2007
University of Maryland
B.S., Cell/Molecular Biology & Genetics
2000 — 2004
Skills
- Public Health
- Regulatory Submissions
- Oncology
- Life Sciences
- Pharmaceutical Industry
- Sop
- Fda
- Regulations
- Medical Devices
- Capa
- Glp
- Drug Development
- Gcp
- Gmp
- Validation
- Clinical Trials
- Regulatory Requirements
- Biotechnology
- Healthcare
- CRO
- Regulatory Affairs
- Lifesciences
- U.s. Food and Drug Administration (Fda)
- Infectious Diseases
- Clinical Development
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