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
- Including the planning, compilation, review and submission of registration documents, and ensure compliance with NMPA and relevant regulatory requirements.
- 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.
- Interpret regulatory requirements and provide professional opinions, offer compliance support for product R&D, production and registration strategy formulation, and avoid regulatory risks.
- Establish a sound registration document system, and ensure the completeness, accuracy and traceability of documents.
Education And Qualifications
- Bachelor's degree or above in a science and engineering-related major.
- Good in oral and written English. Mandarin is a must.
= 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).