Beibei Sun, PhD

Associate Director of Regulatory @ Cerus

About

10+ years of medical device RA experience in strategics and as independent RA consultant. Experience in RA, CA, QA, labeling, field corrective action, legal manufacturer change, NB audits, Class I/II/III device, drug/device combo products, cardiovascular products, active implants, pediatric ENT devices, China UDI application, software and cyber security regulation. US, global, China, Hainan, regulatory affairs. Full Quality System QSD certification for European and US companies in Taiwan. Obtained QSD certificate, product licenses, price listings for the products in Taiwan. Designed and executed the regulatory strategy in Taiwan market. Did all the application from the beginning to the end with direct communication with TFDA and obtained certificates all by myself. NMPA submissions, type testing, clinical study, Hainan Real World Study. Obtained product type testing PTR issuance, NMPA product approval and Hainan pilot zone fast track project application approval. Familiar with international regulatory management, NMPA medical device regulations, US FDA class II and class III medical device regulation, EU CE Mark, TFDA medical device regulation.

Country

United States

City

Santa Rosa

Industry

Medical Device

Skill

Regulatory Affairs, Teaching, Presentations, medical device regulation, international registration, Technical writing, Chinese, AI for Project Management, Artificial Intelligence (AI), Artificial Intelligence for Business, Microsoft Copilot, Project Management, Building Trust, Interpersonal Communication, Personal Boundaries

Experience

Associate Director of Regulatory

Cerus

2022-7 - Present · 4 yrs 3 mos

Sr. Manager Regulatory Affairs

Advanced Bionics

2019-10 - 2022-7 · 2 yrs 10 mos

Santa Clarita, CA, United States

Sr. Regulatory Affairs Manager

JCS Consulting

2018-2 - 2019-10 · 1 yr 9 mos

Santa Rosa, California

Regulatory Affairs Manager

Independent Consultant

2014-10 - 2018-2 · 3 yrs 5 mos

Santa Rosa, California

Milestone: obtained Full Quality System Documentation certification for a European company in Taiwan independently; obtained product licenses in Taiwan independently with direct communication with TFDA. Did all the application from the beginning to the end. Current project: Class II and III combo medical devices registration in Asia, including all document preparation and application process. Liaison between the medical device company in US and Europe and the regulatory body in Taiwan.

Regulatory Affairs Specialist

Medtronic

2012-8 - 2014-9 · 2 yrs 2 mos

Santa Rosa, California, USA

International regulatory affairs in peripheral and coronary business, including new product registrations, renewals, tenders, and queries. SBU liaison on China, Australia, India, EMEA, and Latin America registration. Global regulatory affairs management. Create, review, and approve implementation site addition, manufacturing change orders, essential requirement checklist, and product filed notifications. Led response to BSI desk auditing. Write up PMA annual report, IDE annual progress report, Technical File update, and clinicial study report coordination.