Kedar Pai is a regulatory affairs leader with over 10 years of experience guiding medical device and IVD products through global regulatory pathways. He currently serves as Senior Manager, Regulatory Operations at Intuitive Surgical, where he has led technical documentation efforts for global registrations, served as the regulatory point of contact for third-party (EU MDR and MDSAP) and FDA audits, and built dashboards and KPI tracking tools to accelerate market release. Previously, at Intersect ENT (later acquired by Medtronic), he managed PMA supplements and annual reports for Class III devices, led a successful MDR Full Quality System audit with BSI, and developed US and EU regulatory strategies for manufacturing changes and expanded intended uses. At BD Biosciences, he led the implementation of EU IVDR (2017/746) and obtained the first worldwide Class C EU IVDR certification by BSI — an achievement recognized with a company-wide award.

Kedar's regulatory expertise spans the full product lifecycle, from technical file authoring and clinical evaluation reports to change management, audits, and supporting submissions to agencies including the FDA, Health Canada, ANVISA, TFDA, MHLW, and TGA, gained across roles at Abbott Vascular and Penumbra, Inc. He holds an MBA from UCLA Anderson School of Management and an MS in Regulatory Science from the University of Southern California, and is an active member of the Regulatory Affairs Professionals Society (RAPS). He brings prior speaking experience to the table as well, having presented as a session leader on EU IVDR: An industry perspective at RAP Convergence 2018, Vancouver.