Qserve Group is pleased to announce that Weiwei Wang has joined our team to further expand its capabilities in supporting the medical device & IVD industries worldwide.
Weiwei Wang has over 5 years of 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.
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.
Her key area of expertise include supporting registration strategy for new product registrations and change registrations. Weiwei also has hands-on experience with verification, validation, and analytical study design and analyses for in vitro diagnostic devices as well as preparing and supporting medical device and IVD submissions, including US FDA pre-submissions, 510(k), EU technical files, and China technical dossiers.
About Qserve Group
Qserve’s mission is to support all medical device and in-vitro diagnostics manufacturers with a practical approach, translating existing regulations to understandable requirements. We serve to guide manufacturers in gaining and maintaining compliance as well as conducting clinical studies as a CRO to ensure safe and quality devices in the most streamlined way possible. Qserve’s global team combines its regulatory and clinical knowledge and experience in the medical device industry, sharing more than 900 years’ worth of combined expertise in the medical field. Having teams in the EU, USA, and China provides a global footprint for global regulatory, clinical, CRO and quality services.
Qserve is constantly looking for consultants at different career levels with experience in regulatory affairs, quality assurance, clinical affairs or auditing in medical devices. Check our open job listings.