12+ year experience in the regulatory management of the complete product life cycle of medical devices and IVD. Held leadership positions in RA/QA/QC. Led and executed numerous premarket submission of IVD and passive medical devices. Have extensive training and experience in GMP, QMS and helping companies pass CFDA GMP qualification inspection. Supervised and established 3 medical device manufacturing facilities from grounds up: obtained manufacturing facility CFDA certificates and the associated CFDA products registration.
Worked extensively with CFDA testing centers to support type testing and biocompatibility testing to meet CFDA GB/YY standards
He received BS in bioscience engineering degree from Beijing Union University
Responsible for the construction of the company’s factory buildings and supporting facilities and equipment (including clean workshops); the development and management of company QMS/GMP, products registration and post market compliance (multiple AEs); planning for product development and R&D direction, managed and passed the first physical examination of “Implementation Rules for Aseptic Medical Devices Production”. Established and managed the production workshop for environmental testing, process water quality testing, semi-finished product protein content detection, sterility testing, endotoxin detection, finished product loading detection, moisture content detection, sterility testing, endotoxin detection, isoelectric point Electrophoresis. Assist in routine electrophoresis, rabbit pyrogen test, HPLC and GC detection. Established the operational SOPs involved in the testing in accordance with the National Pharmacopoeia.
Training and Certifications: China Medical Device Industry Association Inspector Training Certificate (Qualified), Internal Auditor of Quality Management System, Aseptic Medical Device Production Management and Quality Control by the National Food and Drug Administration Training Center, Risk Manager Training, Training Institution, Medical Equipment Sterility Testing Staff Training Course by China Medical Device Industry Association.