Pooja Mhambrey

Pooja Mhambrey is a regulatory affairs professional with 8 years of U.S. and international experience in medical devices, including software as a medical device (SaMD) and in vitro diagnostics (IVD). Currently at Amazon, Pooja builds regulatory strategies for medical products and ensures compliance throughout the product development lifecycle. Previous roles included regulatory lead at Natera, where they successfully drove IVDR submissions, and regulatory affairs specialist at HeartFlow, Inc., where they contributed to over 30 product launches. Pooja has a background in quality control and has been trained in agile scrum methodology. They hold a Bachelor’s degree in Pharmaceutical Sciences from Goa College of Pharmacy.