Jonathan S. Helfgott, Program Coordinator, Lecturer
Jonathan S. Helfgott is program coordinator in the MS in Regulatory Science program where he teaches and advices students. Additionally, he is the Director of Global Regulatory Affairs at Stage 2 Innovations. Prior to joining Stage 2 Innovations in early 2015, Mr. Helfgott was formerly the Associate Director for Risk Science, within the Office of Scientific Investigations at FDA’s Center for Drug Evaluation & Research (CDER). Prior to joining CDER in 2010, Mr. Helfgott worked at the FDA’s Center for Devices and Radiological Health (CDRH) within the Division of Bioresearch Monitoring (BIMO).
Mr. Helfgott specialized in Computerized Systems used in FDA regulated Clinical Investigations. Mr. Helfgott has also served as an Adjunct Professor for the JHU M.S. Regulatory Science program since 2011, teaching: Clinical Development of Drugs & Biologics, International Regulatory Affairs, Validation in Biotechnology, & Biomedical Software Regulations. Mr. Helfgott is the Co-Editor of the Food and Drug Law Institute’s 2009 Publication, “Biomedical Software Regulation.” Mr. Helfgott has also been published in Peer Reviewed Journals such as Applied Clinical Trials, RAPS Focus, Association of Clinical Research Professionals, FDLI Update, Touch Briefings, and Medical Device and Diagnostic Industry. Mr. Helfgott also continues to lecture and be involved with various regulatory professional organizations such as DIA, ACRP, RAPS, SoCRA, SCDM, AdvaMed, CHI, CBI, FDANews, and others. Mr. Helfgott co-developed the Software Education Program for the CDRH Staff College through the Medical Device Fellowship Program. Prior to joining FDA in May 2006, Mr. Helfgott conducted genetic research using micro-array technology at the NIH’s National Institute on Aging.
Mr. Helfgott received his M.S. in Bioscience Regulatory Affairs from Johns Hopkins University and his B.S. in Cell Biology and Molecular Genetics from the University of Maryland College Park.