Job Description
Mission/Position Headline:
Clinical affairs including SSME product clinical trial and collaboration support during NMPA approval and R&D process, collect customer feedback on SSME products, support clinical related issues for SSME R&D projects.
Areas of Responsibilities:
· Clinical trial management and clinical trial implementation to support NMPA approval and R&D projects of medical imaging device and medical imaging AI software.
· NMPA and EU clinical evaluation management and implementation for medical imaging device and medical imaging AI software
· Clinical trial/collaboration quality, timeline and cost control and managementustomer;
· Communication with R&D project management team and other internal/external stakeholders
· Other tasks assigned by management
Dimension of Function/Volume:
Be responsible for clinical affairs, including clinical trials & collaboration, clinical evaluation support for SSME products, etc.
Experience
At least 5 years work experience on medical imaging devices & clinical application;
Familiar with China and/or global(especiall EU) clinical trial/clinical evaluation regulation and implementation procedure;
requires good English speaking;
medical background or working experience in radiology department of hospital is preferred.