Ms. Sun brings extensive expertise in Quality Assurance and Regulatory Affairs from over 27 years of experience working for medical device and pharmaceutical companies such as Siemens Healthcare, Alcon (Novartis), Masimo, Watson (Activis), B Braun Medical, and Sakura Finetek USA. Prior to joining AMDI, Ms. Sun held the position of VP of RA & QA at Verrix, LLC, where she established the Quality Management System from scratch and obtained ISO 13485:2016 certification. She has also provided leadership in new product design controls, Pre-submission, 510(k) submission, and follow-up interactions with the FDA. She has worked closely with many international regulatory authorities and has established and continuously improved Quality Management Systems for medical device companies to ensure compliance with applicable regulations and standards. Ms. Sun received her MBA from the Anderson School of Business at UCLA. She also holds an M.S. in Bioengineering from the University of Toledo (Ohio) and a B.S. degree in Biochemical Engineering from the Beijing University of Chemical Technology.
Vice President, Quality Assurance and Regulatory Affairs