Hailey Chu

Hailey Chu is a regulatory lead at BSI since September 2023, specializing in medical device certification. Prior to this role, Chu served as a QA/RA Manager at Beckman Coulter Diagnostics from February 2022 to September 2023, where responsibilities included leading IVD product registration and managing the quality management system. Chu's extensive experience at BSI from November 2009 to February 2022 encompassed roles such as Senior IVD Technical File Reviewer & Certification Manager and Medical Devices Manager, focusing on IVDD/IVDR technical documentation review and ISO auditing. Earlier experience at General Biologicals Corp. includes positions as RA Team Leader, QC/QA Specialist, and R&D Researcher, addressing areas such as CE marking, FDA certification, and the design of immunoassays. Academic qualifications include a Master's degree in Biotechnology from National Dong Hwa University and a Bachelor's degree in Food Science from Tong Hai University.