Primary Job Title Vice President & Regulatory Affairs Primary Organization 
Microbot Medical
Location Hingham, Massachusetts, United States Regions Greater Boston Area, East Coast, New England Gender Female
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Ahava Stein is an expert in regulatory affairs, clinical and quality assurance (QA) specializing in FDA and CE submissions with over 20 years of experience working directly with the FDA, Including regulatory submissions for 510(k), PMA, IDE, Pre-IDE, 513(g), and RFD, for a wide variety of innovative, medical devices and participation in PMA Panel
meetings. She has managed multicenter, clinical studies, participated in numerous BIMO inspections, clinical site inspections in the US, Europe and Israel. She has extensive experience in implementing QA systems at medical device companies, submitting PMA manufacturing sections and participating in a multitude of QSR and ISO 13485 inspections by the FDA and European Notified Bodies.
