Yu-Cheng (Bob) Shen, MS, RAC, is a seasoned professional in regulatory affairs with extensive experience in the medical device industry. Currently serving as a Senior Regulatory Affairs Specialist at Dexcom, Yu-Cheng leads hardware design improvements and has achieved notable regulatory clearances, including the US FDA clearance for the Dexcom G7. Previous roles include obtaining the first FDA 510(k) clearance for VivaLNK's wearable ECG platform and the first CE Mark for its multi-vital platform. Yu-Cheng holds multiple advanced degrees from the University of Southern California, including a Master of Science in Medical Device and Diagnostic Engineering, and is pursuing an MBA at USC Marshall School of Business. With a solid foundation in engineering and regulatory processes, Yu-Cheng has effectively contributed to device advancements and compliance through various internships and positions early in the career.
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