SSME XP Regulatory Compliance Engineer
SIEMENSShanghaiUpdate time: February 28,2023
Job Description
Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Ensure X-ray products and processes complying with relevant international and national standards and regulations; Support imported X-ray products CFDA 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 Internal Contacts: R&D engineer, Q External Contacts: Legal authorities, testing institutes, and contacts on regulatory issues in Siemens Healthineers. Requirement: Experience in Regulatory affairs, IEC 60601-1 series standards, EMC / NMPA process Experience in X-ray product development process Experience with independently completion of market clearance for a certain product in China or other countries Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways. Organization: Siemens Healthineers Company: Siemens Shanghai Medical Equipment Ltd. Experience Level: Experienced Professional Full / Part time: Full-time

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