James Lin

Senior Regulatory Associate

James’s career started when he was the first engineer hired by a start-up to help develop a medical device. After playing pivotal roles in product development, manufacturing, and commercialization, he transitioned to Quality Assurance and Regulatory Affairs. Since then, his work has encompassed all aspects of Quality Systems including managing process improvements, conducting internal quality audits, and participating in FDA on-site inspections. In regulatory, his past work experience includes incident reports to US FDA and Notified Bodies, EU CE Mark submissions, and developing regulatory strategies. In addition to his certifications in regulatory affairs (RAC) and biomedical quality auditing (CBA), James is fluent in English, Chinese, and Japanese. He received a Bachelor of Applied Science degree in Electrical Engineering from the University of British Columbia and a Master’s degree in Electrical Engineering from Imperial College London.