Danaher Corporation Regulatory Affairs Manager in Beijing, China
Timely product registration to NMPA in alignment with business needs. • Coach and mentor regulatory team towards achieving the company ’ s goals. • Define the registration strategy, project planning and implementation to get NMPA and other required certificates within the best possible timeline. • Report projects status to management team in order to identify risk and coordinate the resources for multiple projects. • Communicate with BU, marketing, clinical affairs, logistic, system design and application teams, and related departments, as well as cross functional teams to gain necessary support and alignment. • Interface with NMPA, CMDE, test house, standard committee and other agencies to well understand regulations, guidelines and standards requirements. • Maintain Regulatory Affairs (RA) related procedures and monitor the execution of the RA team. • Control the budget and actual cost of the responsible RA team. • Responsible for hiring/firing/disciplinary decisions affecting direct reports. • Ensure staff skills are developed and maintained on a continual basis to ensure cost/effective operations.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .