Management for safety, regulation items in NPI projects
Involve in safety design in product development, verify the safety design output
Arrange 3rd part test for safety certification of product, such as ITS and CCC
Prepare and submit the documents for product registrations, such as SFDA, MHLW, FDA and CE
Evaluate PSR Report related with Safety and Regulation and follow to fix it
Qualifications:
1. Engineering background.
2. Fluent English communication skill in both spoken and written
3. With Knowledge in International standard (UL, IEC, EN, GB).
4. High competence, can work in high pressure
5. Efficient in problem solving, leadership to drive to complete resolution
6. Team work
General: GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. GE Healthcare’s expertise in medical imaging and information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, and biopharmaceutical manufacturing technologies is helping physicians detect disease earlier and to tailor personalized treatments for patients. GE Healthcare offers a broad range of products and services that are improving productivity in healthcare and enhancing patient care by enabling healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions. Headquartered in the United Kingdom, GE Healthcare is a $15 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 52,000 people committed to serving healthcare professionals and their patients in more than 100 countries. GE is an equal opportunity employer.
GE医疗集团隶属于通用电气公司,年销售总额达140亿美元,是医学影像、信息技术、医疗诊断、患者监护、疾病研究、药物研发以及生物制药等领域的全球领先者。 GE Healthcare Technology/GE医疗集团医疗技术部门在医学影像、信息技术、患者监护系统与医疗服务等领域提供广泛的服务,年销售额达110亿美元。从超声波、磁共振到外科手术导航系统,GE都拥有行业内的领先技术,帮助临床医生比以往更清晰地诊视病人的体内情况。GE患者监护系统和医疗信息技术可以将不同领域的医学影像与数据完美地整合起来,从而提高诊断效率,改善护理质量。同时,我们的技术、培训、流程优化以及金融服务都能帮助医疗机构在临床诊疗与商务运营方面取得更好的表现。 GE Healthcare Bioscience/GE医疗集团生命科学部门是GE医疗集团属下一个年销售额30亿美元的部门。其业务主要包括医学诊断、药物开发和蛋白质分离系统。我们的诊断影像介质用于医学扫描,可以显示出人体内病变的器官、组织、细胞,从而实现疾病的早期探测、诊断与控制。GE的套色版系统和过滤净化系统都被应用于药物开发项目,以便制定出更有针对性、更有效的治疗方法。同时,通过细胞和蛋白质分析、DNA序列、基因表达和基因变异分析,我们的探索系统可以协助功能生物学开发更新、更有效的药物. 中国是GE医疗全球增长的重点。GE医疗利用业务全球化的优势将标有“中国制造”的GE医疗产品推向全球市场,也把国际先进的技术和服务带给中国。中国已逐步成为GE医疗全球重要的研发、生产、采购的中心之一。 立足客户、服务客户;立足中国、服务中国,GE医疗中国正在通过一流的产品质量,全方位的服务和同步于世界水平的先进技术实现自己的承诺。