IVDR Regulatory Affairs
Consultant
Weiwei has over 5 years regulatory experience in the IVD and medical device industries supporting start-ups through multi-national manufacturers. Weiwei started her career as a research and development scientist developing blood based rapid in-vitro diagnostic tests.
Before Qserve
She was involved in various levels of product development life cycle including product design, prototype development, clinical study design, pre-submissions, and 510(k) submissions. She later worked for an ophthalmic medical device company supporting the regulatory submissions in both domestic and international markets. In her last role as the China registration lead at Johnson & Johnson Vision, Weiwei was responsible for the China registration strategy planning, in-country type testing, and technical dossier preparation. She also worked as a key liaison for NMPA regulators, third-party registration agencies, and testing agencies working towards efficient and timely regulatory approvals.
Weiwei has a bachelor’s degree in Clinical medicine (5-year track, US MD equivalence), and holds Master of Science and PhD degrees in Cell and Molecular Biology. She has extensive knowledge in molecular biology, biochemistry, tissue engineering, and regenerative medicine.
The key expertise areas of Weiwei:
• Prepare and support medical device and IVD submissions, including US FDA pre-submissions, 510(k), EU technical files,
and China technical dossier and support registration strategy for new product registrations and change registrations.
• Hands-on experience with verification, validation, and analytical study design and analyses for in vitro diagnostic devices
• Expertise in China registrations including new product, renewal, and change registration.
• Working experience with ophthalmic medical device registrations
• Review medical device standards and guidance and provide advice on conducting on-site and in-country testing with engineering teams
• Drafting and reviewing of Clinical Evaluation Protocols and Reports (CEP/CER)
• Experience with labeling review
• In-depth knowledge of ISO 13485:2016, FDA 21 CFR820, ISO 9001:2015 and cGMP requirements
• Language skills: Chinese, English