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Hemang Kotecha, MS, RAC

Sr. Principal Regulatory Affairs Specialist
Medtronic

Hemang Kotecha is a Sr. Principal Regulatory Affairs Specialist at Medtronic, with 14 years of global experience supporting Class II and III medical devices. His expertise spans a wide range of technologies, including electromechanical systems, infusion pumps, software in medical devices (SiMD), software as a medical device (SaMD), cardiovascular products, combination products, and mobile health applications. Hemang holds a Master’s Degree and is RAC certified. He has successfully led and secured timely approvals for a broad spectrum of regulatory submissions, including FDA 510(k)s, Pre-Submissions, EU MDR Technical Files, Health Canada licenses, and international product registrations. As a regulatory lead on new product development teams, he partners cross-functionally to develop and implement effective global regulatory strategies. He played a key role in leading and obtaining authorization for one of the first non-AI/ML Predetermined Change Control Plans (PCCPs) within Medtronic’s Diabetes Operating Unit—enabling a more efficient regulatory pathway for future device changes. Passionate about mentoring early-career regulatory professionals, Hemang is committed to advancing regulatory excellence and ensuring global access to safe and effective medical technologies through thoughtful leadership, regulatory strategy and collaboration.

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