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Shiven G. is a seasoned professional in Regulatory Affairs, currently serving as Senior Manager of Regulatory Affairs at EBR Systems, Inc. since August 2021, following a notable tenure at Medtronic from November 2014 to August 2021 as Principal Regulatory Affairs Specialist. Shiven G. has extensive experience managing FDA submissions, leading audits, and developing regulatory strategies for medical devices, including high-risk Class II devices. Key achievements include leading significant regulatory projects, conducting training for large teams, and implementing innovative strategies to enhance compliance and business acumen. Educational qualifications include a Master's degree in Medical Devices and Diagnostics from the University of Southern California and a Bachelor's degree in Biomedical Engineering from D. J. Sanghvi College of Engineering.