• Regulatory Affairs Manager

    Requisition ID
    2018-4980
    # of Openings
    2
    Job Location(s)
    Chaoyang District 11 China
    Education
    Bachelor's Degree, Master's Degree
    Position Type
    Full Time
    Category
    Regulatory Affairs
  • Overview

    • As the RA manger, manage registration projects for one division of COOK in China
    • Motivate subordinates to work efficiently, engage into commercial team business
    • Maintain ASC system
    • Take part in the drafting and evaluating Chinese national standard, technical guidance of medical device

    Responsibilities

    • Manage license maintenance for around 100 projects per year, including license extension, variation and IFU filing
    • Work closely with manufacturer RA and local commercial team to support new product registration and introduction
    • Maintain ASC system and ensure regulatory compliance in China. Support company PMS management handling, including spot check, audit, recall…, collaboration with quality team, SC team and compliance team to provide operational support for entire product life cycle
    • Provide clear guidance and action plan to team according to company strategy
    • Strengthen collaboration with industry to take part in regulatory development
    • Shape regulatory environment and provide clear interpretation about China regulation to global team and local commercial team, make assessment based on latest regulatory request to identify potential regulatory risk, set up plan and take actions accordingly to minimize the impact
    • Build good relationship with/partnership with KOL of China government

     

     

    Qualifications

    • Bachelor’s degree or above in related scientific discipline; Medical or pharmaceutical background is preferred
    • With a minimum of 5 years regulatory experience in Regulatory Affairs in Medical Device Industry, including managing people or projects;
    • Fluent English speaking and communication
    • Excellent oral and written communication skills and strong negotiation skills
    • Clear and full understanding of medical device regulation and approval processes

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