Boyang Zhang, RAC

Primarily responsible for the regulatory activities all access devices in China. - New product submissions - Sustaining activities for approved products - PLM management for approved products - Process optimizations Regulatory affairs inteligence. External audit support and internal audit lead.

- Support pre-market and post-market regulatory activities (US, EU, CA)for Class III cardiac ablation catheters. - IDE submission/maitaining, PMA preparation - Clnical study application in EU - Audit support - Supported on-going clinical studies and applied for new clinical studies. - MDD to MDR transition - Evaluated proposed changes in all aspect related to the products for regulatory impact and prepare change notification/application when needed.

- Managed to team to provide document translation and dossier compilation services in support of regulatory affairs devision of clients (including: Fresenius, Boston Scientific, GE Healthcare, Zoetis, Cstone Pharmaceutical, Align Technology, Huadong Pharmaceutical, Sunshine Guojian). - Helped prepare IND/NDA filing for drugs and clinical trial application, registration application (equivalent to IDE/510k/PMA filing) for devices. - Introduced CAT system with various softwares incorporated into a streamlined production pross that achieve quality and efficiency. - Received training on eCTD sumission, medical device registration application, IND/NDA application, and QMS.

• Participated and lead the registration filing and follow-up for multiple pharmaceutical products (6 in total). • Communication with the regulatory agency to settle issues in dispute with goals accomplished. • Coordinated with local PI for the conduction of clinical trials, and with testing institute for the product inspection. • Provided regulatory insights for commercial decision making. • Participated in the optimization of the registration preparation process which shortened the time frame during dossier preparation.

Regulatory affairs tasks related to animal health product (with focus on pharmaceuticals) - Dossier preparation and filing - Registration renewal - Change to registration - Site transfer Aquired fundemental understanding of the regulatory framewok, working process, and policy trends.