This role will ensure clinical evaluation include clinical evaluation report, clinical study design and clinical study report successfully complete, compliance with the regulatory requirement. 1. Support the development of the clinical evaluation report across the product lines, review the CER to ensure it meet the requirement of CMDE; 2. Support for Clinical Evaluation Artificial Intelligence related questions; 3. Support for the CER supplemental request, including the document writing and communication with reviewers； 4. Support to develop clinical study documents, including protocol, investigator brochure, clinical study report etc., in compliance with regulations of China. 5. Support the clinical study archivingas needed, ensure the archived docs comply with GCP. 6. Support on the clinical relevant SOPs improvement. 7. Consistent and effective communication to all internal and external stakeholders; Product registration and certification Internal: RA, CA, and other relevant parties. Education 1. Master degree or above relevant in Artificial Intelligence/Clinical/Medical/ Biomedical engineering.