• Regulatory Affairs Specialist

    Requisition ID
    # of Openings
    Job Location(s)
    Chaoyang District 11 China
    Less than 10%
    Bachelor's Degree, Master's Degree
    Position Type
    Full Time
    Regulatory Affairs
  • Overview

    Handle the affairs about regulatory plans, Product standard, communications and perform gap analysis.


    • Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations;
    • Draft Product standard according to COOK internal specification and External standard;
    • Establish appropriate communication with manufacturer's RA team and Local Business Unit.
    • Perform gap analysis on SFDA requirement and propose solutions;
    • 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 3 years regulatory experience as RA function in medical device industry;
    • Sound basis of Regulatory knowledge and Scientific Knowledge.
    • Good skill on Word, Excel and PowerPoint
    • Ability to manage projects and timelines in a matrix team environment;
    • Strong oral and written communication in English and Chinese


    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed