琳韩

Sr. Manager Regulatory Affairs @ Dexcom

About

I'm a professional person in Regulatory Affairs, have great experience in RA/QA team management and Regulatory Affairs strategy. Over 18 years working experience in medical device area. Have done allogeneic implantation registration, Extensive active and inactive medical devices. Good business understanding in multiple medical device and Infection control area. High adaptability to face challenges, deadlines and fast paced changes; capability of teamwork, quick learning; and enthusiasm.

Country

China

City

Chaoyang District

Industry

Medical Device

Skill

医疗设备, FDA, 法规事务, CFDA, 医疗器械注册

Experience

Sr. Manager Regulatory Affairs

Dexcom

2024-2 - Present · 2 yrs 8 mos

Senior Staff of Regulatory Affairs

HTDK Medical Group

2022-2 - 2024-2 · 2 yrs 1 mo

Beijing, China

Senior RA/QA Manager China & Hong Kong

Cantel Medical

2012-8 - 2021-10 · 9 yrs 3 mos

Beijing China

• Manage Regulatory Affairs and compliance activities for Cantel China’s Endoscopic Class II & III medical products and disinfection products lines for all of China and Hong Kong • Oversees the registration of new Cantel Endoscope and Disinfection medical products and maintenance of existing product licenses with NMPA, MOH and other regional regulatory agencies. • Act as a senior leader for the Regulatory Affairs department. • Oversee the Regulatory Affairs department audit and compliance activities