China General Manager, CFDA and Clinical study Expert
CFDA and Clinical study Expert
Stephanie Huang is general manager of Qserve Group China since its establishment. Besides her management role, in which she is developing regulatory strategies, performs gap analysis, strengthens east-west connections within Qserve as well as in the companies served by Qserve China, she focusses on China CFDA compliance in medical devices field.Graduated with MCom from University of Sydney, she has spent several years studying and working in China, UK, and Australia.
Prior to joining Qserve in 2012, She worked for a British pharmaceutical contract research organization (CRO) based in Nanjing, and was involved in project management on pharmaceutical and medical device products, and targeted suitable partners for both western and eastern clients. By connecting and leveraging stakeholders’ strengths, she supported a number of companies to extend activity scope and technology capabilities on clinical research development.
She is familiar with local pharmaceutical and medical device industries, regulatory and culture environment. Stephanie combines in depth understanding of CFDA requirements with excellent communication skills.