Senior Regulatory compliance engineer is going to
- Ensure X-ray products (esp. mobile c-arm x-ray system) and processes complying with relevant international and national standards and regulations;
- Support imported X-ray products NMPA licensing;
- Plan and monitor the regulation test during the projects
1. Ensure product and process compliance with relevant national and international laws and regulations.
2. Responsible for IEC60601-1 series standards including EMC testing of X-ray products.
3. Responsible for NMPA testing.
4. Cooperate and Coordinate closely with new project team to ensure market clearance and other compulsory certification process smoothly and efficiently.
5. Support imported X-ray products NMPA testing.
6. Cooperate with sub-system from requirement definition, test plan alignment and finally the test report review to make sure the quality and timeline at system side
Bachelor degree is must, Master is preferred
Organization: Siemens Healthineers
Company: Siemens Shanghai Medical Equipment Ltd.
Experience Level: Experienced Professional
Job Type: Full-time