Jane is Senior consultant at Qserve Group China, based in the capital city, Beijing. She develops regulatory strategies for various medical devices; manages and schedules the process of preparing, coordinating and submitting regulatory applications to CFDA to ensure compliance with government and company standards.
Jane has 18 years of regulatory affairs experience in China. She has worked on ophthalmic devices and optical products, such as IOLs, ophthalmic OCT, visual field analyzer, laser devices such as femtosecond laser and excimer laser, YAG, 532s, ophthalmic and surgical microscopes, bio-microscopes, software etc. In addition, Jane has 8 years of medical doctor background, and she has been engaged in the clinical trials in a pharmaceutical company.
On top of her medical training and experience, she received a Master of Management degree from the Norwegian School of Management BI and Fudan University. Jane combines an in-depth understanding of CFDA regulatory and clinical requirements with strong communication and negotiation skills.
“Qserve group is a small company compared to previous international companies I worked for, it has attracted me as Qserve group possesses first-class professional level and service in the field of regulations. I took part of EU-MDR training while I just joined Qserve and I felt that the employees not only have rich MDR knowledge but also have an intelligent mind. I once served as a RA/CA leader in different well-known medical device companies, but Qserve changed my working style. I can directly provide CFDA regulatory service for foreign clients as a senior consultant and helped clients to obtain CFDA approvals since I started working for Qserve in October 2016. Meanwhile, I also got highly praise and trust from customers which makes me feel proud to be a Qserve consultant.”
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