• Regulatory Affairs Specialist

    Requisition ID
    2018-4322
    # of Openings
    1
    Job Location(s)
    Chaoyang District 11 China
    Travel
    Less than 10%
    Education
    Bachelor's Degree, Master's Degree
    Position Type
    Full Time
    Category
    Regulatory Affairs
  • Overview

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

    Responsibilities

    • 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.

    Qualifications

    • 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

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