上海招聘

Mission/Position Headline: 

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.

Experience:

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

Education:

Bachelor degree is must, Master is preferred.

在西门子医疗，我们的目标是通过全面实现数字化医疗，助力医疗服务提供者在各自领域推进精准医疗、转化诊疗模式、改善患者体验，以全方位助力其提升价值。每一天，全球有五百万名患者在影像诊断、临床诊疗、实验室诊断、分子医学以及数字化医疗和企业服务方面受益于我们的创新技术和服务。拥有超过170年历史，在全球范围内持有18,000个专利，西门子医疗是领先的医疗技术公司。我们在全球超过70个国家约50,000名员工将继续创新，塑造医疗行业的未来。
At Siemens Healthineers, our purpose is to enable healthcare providers to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, and improving patient experience, all enabled by digitalizing healthcare.
An estimated five million patients globally everyday benefit 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.
We are a leading medical technology company with over 170 years of experience and 18,000 patents globally. With about 50,000 dedicated colleagues in over 70 countries, we will continue to innovate and shape the future of healthcare.