Sr. Specialist, Regulatory Affairs - China (Hybrid)

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Position Overview

Responsible for executing the aim of timely approvals in China. Execute the regulatory affairs activities for MVI products, including new product, license change, and extension; assure the company’s regulatory affairs activities are conducted accurately and ethically based upon the latest relevant regulations and standards; and ensure regulatory compliance against NMPA requirements for all relevant aspects regulatory strategy and plan which is in alignment with regional marketing and global business plans. Coordinate the NMPA post market inspections within the company including ISO 13485, NMPA local, state, and/or federal quality requirements. Job duties:
  • Act as the RA Project Lead when supporting China product registrations and other regulatory filings (e.g., green channel, priority review, etc.).
  • Support the regulatory strategy and plan development with the MVI Marketing team and provide input to regulatory strategies and compliance to China regulatory requirements.
  • Develop the regulatory strategy and plan timeline establishment for China submission based on approved regulatory strategies and the requirements of the MVI Marketing team.
  • Prepare, write, review, and file NMPA (China FDA) regulatory submissions, and maintain registered products dossiers on RYMSIS to ensure alignment of regulatory strategy and plans with the team objectives.
  • Create and maintain the Tracker to ensure the deliverables required for submission or supplementary notice response are comprehensively captured converting all relevant aspects and updated timely when progress is made.
  • As a key member of China RA group, is able to demonstrate flexibility as priorities change, and coordinate and prioritize tasks with oversight.
  • Work with post-market team in support of the China Periodic Safety Update Reports (PSUR) generation.
  • Plan and implement procedures, practices, and strategies for related projects.
  • Support the activities pertaining to the Product Technical Requirement (PTR) draft and type testing. Communicate with NMPA test lab for related type test topics ensuring to obtain the type test report.
  • Manage the maintenance of the China Regulatory Project Executive Summary for the responsible projects.
  • Maintain up-to-date regulation knowledge and support implementation of new standards and regulations.
  • Communicate with CMDE on routine submission matters such as submission files, supplementary notice response, etc.
  • Work with local government authority for obtaining product approval promptly and correctly.
  • Provide support to overseas and domestic quality inspection.
  • Responsible for preparing labeling per #6 Decree requirement.
  • Train and guide junior RA staff or contractor for completing the tasks assigned to the team.
  • Perform other duties and responsibilities as assigned.


Job Details

    1. Bachelor’s degree in Science, Engineering, or Medical Technology, or equivalent combination of related experience and education.
    2. A minimum of four (4) years of Pharmaceutical or Medical device industry related experience in quality assurance or regulatory affairs, preferably supporting international submission.
    3. Demonstrated understanding of NMPA medical device regulatory requirement (at minimum, Decree 739# and the order of 47# order along with its lower-level regulations, CMDE guidance documents pertaining to medical device registration matters, etc.), China GB/YY standards, as well as fundamental US FDA recruitments posed on medical device.
    4. Proven analytical abilities and organization skills.
    5. Strong interpersonal and written and verbal communication skills.
    6. Ability to comprehend technical documents and concepts.
    7. Knowledge about pre-clinical and post-clinical study.
    8. Comprehensive knowledge about Biocompatibility Test.
    9. Ability to read blueprint and engineering drawing.
    10. Ability to comprehend technical documents and concepts.
    11. Experience in preparation of Class III international submission.
    12. Strong ability to read, write and speak English and Chinese.
    13. Ability to work well in a team environment.
    14. Proficient with MS Office Suite.
    Desired Qualifications
    1. International Regulatory Affairs experience (Preferred NMPA registration experience).
    2. Previous China Regulatory Affairs experience a major plus.
    3. Master’s degree in Science, Engineering or Medical Technology.
    4. Knowledge of US FDA, EU MDR or NMPA medical device regulations.
    5. Ability to work independently and manage multiple priorities effectively with a high attention to detail.
    6. Proven analytical abilities and organization skills.