- As the RA team leader, manage registration projects for all COOK manufacturers in China
- Team management
- Maintain ASC system
- Take part in the drafting and evaluating Chinese national standard of medical device
- Team management of China regulatory affairs department and set RA internal SOP
- As the RA team leader, manage registration projects for all COOK manufacturers in China. There are more than 200 projects per year.
- Monitor applicable regulatory requirements; assure compliance with Cook and external standards;
- Maintain ASC system and ensure regulatory compliance in China
- Communication and collaboration with all Cook facilities ,provide updated Chinese regulation information , perform gap analysis and propose solutions;
- Take part in the drafting and evaluating Chinese national standard of medical device as the member of China national standard committee(sub-branch of Biological evaluation of medical device and Surgical implant committee)
- Build good relationship with/partnership with KOL of China government
- Take part in activity of American Chamber of commerce and China association of medical device industry on behalf of Cook and affect KOL’s attitude
- Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements.
- Bachelor’s degree or above in related scientific discipline; Medical or pharmaceutical background is preferred
- With a minimum of 10 years regulatory experience in Regulatory Affairs in Medical Device Industry, including managing people or projects;
- Sound basis of Regulatory knowledge and Scientific Knowledge;
- Excellent English skill.
- Ability to manage complex projects and timelines in a matrix team environment;
- Strong oral and written communication and presentation skills in English and Chinese;
- Demonstrated interpersonal skills including strong negotiation skills;
- Ability to independently identify compliance risks and escalate when necessary;
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