Li Tzu Wang
About Li Tzu Wang
Li Tzu Wang is a Regulatory Affairs Specialist at Boston Scientific, with extensive experience in regulatory roles across various organizations and expertise in managing submissions and approvals for medical devices.
Title
Li Tzu Wang holds the position of Regulatory Affairs Specialist. Currently, she is employed at Boston Scientific.
Company
Li Tzu Wang is currently working at Boston Scientific in the role of Regulatory Affairs Specialist. She has been with the organization since 2019 in the Greater Los Angeles Area.
Professional Background
Li Tzu Wang has an extensive background in regulatory affairs and the pharmaceutical industry. She has worked at Alcon in Santa Barbara, California as a Regulatory Affairs Specialist from 2017 to 2018. Prior to that, she was employed at USC Regulatory Science Consulting Center as a Regulatory Coordinator from 2015 to 2016 in Greater Los Angeles Area. She also served as a Regulatory Affairs Pharmacist at Tradshine Co., Ltd. in Taipei City, Taiwan from 2014 to 2015. Her early career includes a position as a Pharmacist at Taipei Hospital, Ministry of Health and Welfare in New Taipei City, Taiwan from 2013 to 2014.
Education and Expertise
Li Tzu Wang graduated from the University of Southern California with a Master of Science in Management of Drug Development. She also holds a Bachelor of Science in Pharmacy from Taipei Medical University. Her expertise includes regulatory submissions and approvals for medical devices, international market registrations, and compliance with various health regulatory bodies.
Regulatory Submissions and Approvals
Li Tzu Wang's role involves supporting the registration and submission of Neuromodulation devices in international markets like South Korea, Taiwan, and Singapore. She is experienced in submitting FDA 30-day Notices and 180-day PMA supplements for engineering and sterilization site changes. Additionally, she handles the submission of Health Canada License Amendments and Annual Reports.
Medical Device Compliance
Li Tzu Wang actively participates in the EU MDR Basic Unique Device Identification (BUDI) data collection process and reviews and approves Change Notifications related to manufacturing processes, design, or supplier changes. She works with Class III medical devices such as the Vercise Deep Brain Stimulation System and the Precision Spinal Cord Stimulator System.