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Jonathan Helfgott

Senior Lecturer & Program Coordinator
Krieger School of Arts & Sciences Johns Hopkins University

Jonathan Helfgott is an FDA regulatory, clinical, and market access expert, specializing in the commercialization of medical products at all phases of development. Jonathan has overseen global clinical research and regulatory activities, including overall product development, approvals, submissions, clinical trial design/conduct, inspections, and communications with health authorities and payors. Jonathan is the Founder of FDA Partners, a boutique advisory firm.

Before joining the private sector, Jonathan worked at the FDA from 2006-2015, most recently serving as the Associate Director for Risk Science within the Office of Scientific Investigations at the Center for Drug Evaluation & Research (CDER). He also served as a compliance officer and pre-market reviewer at the Center for Devices & Radiological Health (CDRH), specializing in Digital Health Technologies (DHTs) and Software in/as a Medical Device (SiMD/SaMD).

Earlier in his career, Jonathan worked at the NIH’s National Institute on Aging supporting study designs and genomic research as an Intramural Research Training Award (IRTA).

Jonathan serves as Faculty, Senior Lecturer, and Coordinator for the MS in Regulatory Science & Food Safety Regulation Programs at Johns Hopkins University (JHU).

Jonathan also serves as the President of the Association of Graduate Regulatory Educators (AGRE), and has lectured extensively at various other academic institutions and professional organizations.

Jonathan’s work was highlighted in the Washington Post’s article titled “Regulatory Science Degrees Help Researchers Think Outside The Lab”. He is co-editor of the Food and Drug Law Institute’s Biomedical Software Regulation, Team Member of the Clinical Trials Transformation Initiative – Digital Health Technologies, and also published several articles for Applied Clinical Trials and Medical Device and Diagnostic Industry.

Jonathan received his MS from Johns Hopkins University in Bioscience Regulatory Affairs and his BS from University of Maryland College Park in Cell/Molecular Biology & Genetics.

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