Senior Regulatory Specialist in Nanjing at Stryker Corporation

Date Posted: 8/7/2018

Job Snapshot

  • Employee Type:
  • Location:
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

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

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team