• Regulatory Affairs Director

    Requisition ID
    2018-3677
    # of Openings
    1
    Job Location(s)
    Chaoyang District 11 China
    Travel
    10-20%
    Education
    Bachelor's Degree, Master's Degree
    Position Type
    Full Time
    Category
    Regulatory Affairs
  • Overview

    • 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

    Responsibilities

    • 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.

    Qualifications

    • 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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