Ensure X-ray products and processes complying with relevant international and national standards and regulations; Support imported X-ray products CFDA licencing;
Areas of Responsibilities:
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 CFDA&CCC testing.
4. Cooperate and Coordinate closely with new project team to ensure market clearance and other compulsory certification process smoothly and efficiently.
5. Communicate with Government office and Siemens internal relevant organization to set up a network to improve market clearance process.
6. Support imported X-ray products CFDA&CCC testing.
Dimension of Function/Volume:
Implementation of relevant international and national standards and regulations. Relationship with Authority.
1. Experience in Regulatory affairs, IEC 60601-1 series standards, EMC /CFDA&CCC process
2. Experience in X-ray product development process
3. Experience with independently completion of market clearance for a certain product in China or other countries
Bachelor degree is must, Master is preferred.
Organization: Siemens Healthineers
Company: Siemens Shanghai Medical Equipment Ltd.
Experience Level: Experienced Professional
Job Type: Full-time