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Johnson & Johnson 职业机会

RA Director, Medical Device

北京, 中国
Regulatory Affairs


Requisition ID: 1905764607W

Lead JJMC CSS RA team to create a high standard of performance, create a trusting and collaborative working environment, develop regulatory strategy and drive strategy implementation to support JJMC CSS business growth, lead and develop regulatory team to achieve below objectives;
● Adherence to J&J credo and industry code of conduct, ethics and good regulatory practices, align team members with J&J credo. Ensure 100% compliance with local legislation, global regulatory policies, J&J credo
● Providing guidance or advice for product development and registration strategy to both global and local relative Dept. according to micro & macro regulatory environment and the changes. Ensure the on-time approval for Ethicon products within pre-defined percentage.
● Leading and effectively coaching RA teams to deliver product registration, regulatory compliance, improve efficiency and competency, building up high performance team
● Motivating and inspiring subordinates to work efficiently, engage into business
● Leading RA teams on shaping regulatory environment, taking the leading role in industry
● Strengthening collaboration with NMPA, provincial MPA, Chinese GB/YY standard technical committees and other external stakeholders such as but not limited in government labs, industry associations
● Crisis management

Bachelor degree or above in related majors, for example but not limited to medicine, pharmacy, biomedical engineer, etc.
At least 15 years of regulatory experience.
At least 8 years of people management experience and at least 5 years of people manager management experience
Excellent communication skill in both Chinese and English.

Regulatory Affairs
Requisition ID