Jing Nie

Director Regulatory Affairs & Regulatory Compliance (China) @ Terumo Neuro

About

Accomplished and passionate leader with proven success in influencing & shaping China and Asia-Pacific region business through successfully regulatory strategies, vision, and execution. Proven ability as regulatory leader adept at building trusting relationship, cultivating collaboration, influencing, and improving processes and fostering talents. Track record in leading regional and cross-functional teams to top performance with diverse experiences in medical device industry.

Country

United States

City

Aliso Viejo

Industry

Medical Device

Skill

FDA, Medical Devices, Regulatory Affairs, U.S. Food and Drug Administration (FDA)

Experience

Director Regulatory Affairs & Regulatory Compliance (China)

Terumo Neuro

2022-5 - Present · 4 yrs 5 mos

Aliso Viejo, California, United States

Director of ASPAC Regulatory Affairs Liaison with Supply Chain

Johnson & Johnson

2016-7 - 2022-5 · 5 yrs 11 mos

APAC

Lead regional regulatory portfolio teams and partnering with functional stakeholders (marketing, medical affairs, supply to develop robust growth strategies ensuring successful ASPAC business planning & implementation. Co-chair for APECMED China COE; member of regulatory intelligence of APECMED ASPAC region.

Associate Director Regulatory Affairs

Johnson & Johnson

2012-10 - 2016-7 · 3 yrs 10 mos

Shanghai

Regulatory associate director with leading diverse business units in China including infection prevention, electrophysiology, surgical and non-surgical aesthetics, orthopedics, neurovascular, diabetes care medical device and CDx IVD reagents for NPI, NPD and lifecycle activities. A&D lead in China and domestic manufacturing site transfer. Member of SAC/TC136 IVD clinical diagnostic standard committee and MIIT RoHS and China CDC sterilization association for ASP. Member for AHWP WG7 quality management.