长沙招聘

- For our Healthcare Sector we are looking for a Senior Regulatory Specialist at the earliest opportunity.
- The Senior Regulatory Specialist is responsible for getting product licenses (SFDA and CCC) timely.

What are my responsibilities?
1. Work with regulatory partner in GGs to achieve product licenses (SFDA registration and/or CQC Certificate) for certain responsible product lines
2. Communicate with relevant government departments, institutions and test bodies on product regulatory or technical requirements. And monitor changes in the requirements
3. Update or report the product regulatory or technical requirements to business units and working partners in respected product lines
4. Manage product testing conducted by Chinese test body to achieve test report for product registration

5. Coordinate authority inspection to manufacturers to get certification of responsible product lines

6. Maitain or develop good working relation with certification or testing body, as well as relevant government department to improve working efficiency
7. Involve in or coordinate activities in product standard development or revision.

What do I need to qualify for this job?
1. 3-5 years experience in working with foreign colleagues, and possession of good appraisal
2. Good experience in medical device regulatory affairs
3. Good experience in medical device registration and certification
4. Good knowledge and full understanding in regulations
5. Good experience in regulatory affairs and licensing
6. Good knowledge in medical device standards
7. Good communication Skill
8. Good skills in problem solving in licensing
9. Good English and Chinese
10. Ability of working in high pressure

What else do I need to know?
- The Siemens Healthcare Sector is one of the world's largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source – from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs some 51,000 employees worldwide and operates around the world. In fiscal year 2011 (to September 30), the Sector posted revenue of 12.5 billion euros and profit of around 1.3 billion euros. For further information please visit: www.siemens.com.healthcare

How do I apply?
- We are looking forward to receiving your online -application.
- To submit your application on-line, please click the button “Apply”.

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　　西门子医疗是全球医疗领域最大的供应商之一，是医学影像、实验室诊断、医疗信息技术和助听器等领域的领军者。西门子通过统一渠道向客户提供全方位诊疗产品和解决方案——从早期检测、诊断到治疗和后期护理。通过优化最常见疾病的临床工作流程，西门子还加快了医疗服务速度，提高了服务质量，增加了服务成本的有效性。同时，西门子也是创新型听力设备的市场领军者。

　　西门子致力于为中国全面提升医疗服务提供支持，西门子也一直强调满足中国不同地区与不同层次医院的需求，这包括从领先的医疗科研机构与医院，到病人流通量大的大型综合性医院，从城市社区医院到中小型乡镇医院的各种需求。