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LEENA KADAKIA, BS, MS, is a dedicated regulatory affairs executive with over 20 years of experience in regulatory product development from initial concept to commercialization. Her executive and consulting experience spans strategy, compliance, worldwide regulatory submissions, project management, design controls, design verification and validation, risk management, quality assurance, and clinical affairs. Additionally, she has expertise in leading interactions and negotiations with FDA resulting in successful submissions. Kadakia received a Bachelor of Science in Chemical Engineering from the Massachusetts Institute of Technology and a Master of Science in Biomedical Engineering from Johns Hopkins University. She is RAC-US certified from the Regulatory Affairs Professional Society, and she is a named inventor on multiple patents.