Job Summary:

In compliance with the company’s compliance requirements and China’s regulatory requirements, fulfill the registration projects, certificate management, and document archiving of non-active implantable medical devices.

Main Responsibilities:

1. Including the planning, compilation, review and submission of registration documents, and ensure compliance with NMPA and relevant regulatory requirements.
2. Be responsible for communication and coordination with regulatory authorities such as NMPA, CMDE, and testing centers; handle issues including supplementary information requests and review inquiries during the registration review process; and promote the efficient implementation of registration projects.
3. Interpret regulatory requirements and provide professional opinions, offer compliance support for product R&D, production and registration strategy formulation, and avoid regulatory risks.
4. Establish a sound registration document system, and ensure the completeness, accuracy and traceability of documents.

Education and Qualifications:

1. Bachelor's degree or above in a science and engineering-related major.
2. Good in oral and written English. Mandarin is a must.
3. >= 5 years or more of work experience in medical device registration, with at least 1-2 successful registration cases of Class III implantable medical devices (project experience shall be provided as evidence).