Edwards Lifesciences (S) Spec, Regulatory Affairs in Beijing, China
Facilitate the different functions within the company for the establishment or improvement on the different internal procedures relevant with RA.
Maintain the JDE system RA gateway, make sure all the data upload to the system timely and accurately, address and facilitate the improvement of the RA gateway.
Facilitate the monthly meeting, monthly reports within the department and cross-department within the company both for China and for global
Collect, consolidate, interpret the new CFDA regulation and policy, facilitate the discussion within department and cross-department if necessary. Assist the China RA head to interpret the regulation business impact to the management team.
Facilitate the budget planning and the finance, relevant issues for the China RA department
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.