Regulatory Affairs Expert
Michael is part of the Chinese Regulatory Affairs team providing CE certification and NMPA (former) CFDA registration. Areas of expertise include regulatory strategy, design verification, and CER writing.
The key expertise areas of Michael
- Developing business networking and managing partners/clients locally and globally
- Developing and implementing regulatory strategy, planning and initiating operations for start-up and multi-national companies
- Regulatory (in-house) training regarding China regulatory environment, regulations updates
- Advice on practical interpretation of regulations and laws
- Conduct and advice on-site testing (product design verification) with product engineering team and test labs
- Developing and implementing clinical trial according to (China) GCP and other requirements, advising or writing clinical evaluation report based on guidance
- Preparing technical files and other necessary documents for submission purpose
Michael has over 12 years’ work experience in the regulatory affairs sector, with a major focus on medical devices industry working primarily in industry. As RA specialist, he has strong experience with product registration for NMPA(former CFDA), FDA and CE certification.
Working for both domestic and international companies, such as Brainlab, Medtronic, and Varian Medical Systems. Product areas include radiotherapy/oncology solutions, software, image guided surgery system, deep brain stimulation implants, as well as non-active implants and disposables.
He earned his B.Sc. in International Economy and Trade (Beijing Foreign Studies University), as well as a B.Sc. in Pharmacology (China Pharmaceutical University, Pharmacy).
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