Saket Bhatt

Saket Bhatt, RAC, is a Regulatory Affairs professional with extensive experience in preparing and managing medical device regulatory submissions to prominent agencies like the US FDA and European Notified Bodies. They currently serve as the Vice President of Regulatory Affairs & Quality Assurance at SOVATO and as a Principal Consultant at Prism Health Consulting. Previously, they held several leadership roles, including Vice President of Global Regulatory Affairs at Outset Medical, Inc., and Director of Regulatory Affairs at AliveCor Inc. Saket holds a Master of Science in Biomedical Engineering from the University of Southern California and a Bachelor of Science in Biomedical Engineering from the University of Mumbai.