Senior Regulatory Specialist in Nanjing at Stryker Corporation

Date Posted: 8/7/2018

Job Snapshot

  • Employee Type:
    JTNS
  • Location:
    Nanjing
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/7/2018
  • Job ID:
    R401673

Job Description

  • Responsible for ensuring Regulatory Compliance for the facility and products produced by Stryker.  Creates and drives a culture of Quality and Compliance assisting the organization to ensure the promotion and awareness of regulatory requirements.
  • Continuously fully comply with all GMP and Regulatory requirements.
  • Provide guidance on Quality Assurance/GMP/FDA-QSR and CFDA related topics
  • Involved in developing, modifying, and executing regulatory related company guidelines and procedures.
  • Prepare registration dossier based on registration planning and regulatory authorities’ requirements, including new and renewal registration.
  • Outline the regulatory requirements associated with quick win projects or specific projects including providing regulatory counsel at the team meeting and identifying the need for regulatory involvement
  • Co-ordinate and communicate with project team to work out the registration time schedule according to Product Development Procedure in place.
  • Build the process for handling post market issues for product that is produced by Suzhou.。
  • Will train others and the organization to the applicable GMP/FDA-QSR/and local regulatory standards.
  • Support to any regulated external inspection, ie. FDA / CFDA / or other government body.
  • Responsible for the strategic development of the quality management system in accordance with relevant regulatory requirements for medical devices.
  • Providing technical leadership in the area of Regulatory Affairs. Has responsibility to ensure all necessary regulations are met in order to receive regulatory certification.

Work From Home: No

Travel Percentage: None

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