With over 15 years of experience working as regulatory affairs professional in medical device industry my experience covers a wide range of products: Medical imaging system, physiology monitoring devices, minimally invasive surgical devices, and software as medical devices. My role includes defining global regulatory strategies, ensuring product compliance during the development phase, and obtaining product approvals globally, specifically in EU (CE marking) and USA (510(K). As a native Chinese speaker I bring with me also has an in-depth understanding of NMPA regulatory, guidelines, standards and clinical requirements with strong communication and negotiation skills.
During my career as regulatory affairs professional, I also gained experiences in the advanced development phase, which includes preparing clinical strategies from a regulatory perspective, obtaining CA, EC or IRB approvals.
As strong advovate of lean and agile methods I am particularly interested in the early stages of developing a device and assisting companies who are struggling with regulatory dynamics.
I hold two master’s degrees in Biomedical Engineering and Innovation Science and am Regulatory Affairs Certified (RAC Devices).