Ensure X-ray products and processes complying with relevant international and national standards and regulations; Support imported X-ray products CFDA licencing;
Areas of Responsibilties:
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 othercompulsory 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 andnational standards and regulations. Relationship with Authority.
Experience in Regualotory affairs, IEC 60601-1 series standards, EMC /CFDA&CCC process
Experience in X-ray product development process
Experience with independently completion of market clearance for a certain product in China or other countries
Bachelor degree is must, Master is prefered
Our global team:
Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.
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Job ID: 179391
Organization: Siemens Healthineers
Company: Siemens Shanghai Medical Equipment Ltd.
Experience Level: Experienced Professional
Job Type: Full-time