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Kim Ky

Manager, Regulatory Affairs at Q'Apel Medical

Kim Ky has extensive experience in regulatory affairs within the medical device industry, currently serving as the Manager of Regulatory Affairs at Q'Apel Medical since January 2022. In this role, Kim oversees cross-functional teams in the development and submission of both domestic and international regulatory documents, including 510(K) submissions. Previous experience includes leading regulatory activities at ZAP Surgical Systems, directing submissions at Carl Zeiss Meditec AG, and creating international regulatory strategies at ZELTIQ. Notable achievements encompass building the International Regulatory Department at Natus Medical and successfully obtaining 510(k) clearance for a class I device at Acclarent. Kim holds a Bachelor of Science degree in Biological Science from Cal State University-East Bay.

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