深圳招聘

职位描述：

- For our Healthcare Division in SHENZHEN,we are looking for a (SSMR)(MR)Regulatory Affairs Specialist for Medical Device(CFDA).

What are my responsibilities?

1. Identify the mandatory techinical standards and regulations that our products need to be fulfill and keep them up to date

- 识别产品需要满足的强制性技术标准及法规并维护更新

2. Get the CFDA Approval for the products.

- 负责公司产品在中国的CFDA注册认证。

3. Ensue all products accord with Chinese regulations and standards.

- 确保所有产品符合中国地区的法规和标准。

4. Supprt foreign Bus RA/Sales for local audit and invite public bidding.

- 为国外业务部门的法规食物和市场竞标提供法规支持

5. Maintenance of the license for production and operation in the scope of medical device regulations.

- 医疗器械嘎贵内生产/经营许可证的维护

6. Has the authority and is obliged to stop any processes and projects in cases where the corresponding regulation and standard requirements are not fulfilled.

- 有权利及义务制止任何不满足法规和标准的流程及项目

What do I need to qualify for this job?

- Perfect technical writer /优秀的技术文档编辑能力

- Public relations/良好公共关系能力

- medical device product knowledge/医疗器械产品知识

- benchmarking, audits, reviews, assessments/基准比较,审核,评审和评估方法

- train-the -trainer/对培训者的指导方法

- perfect english/流利的英文

- quality assurance know -how, product safety and risk management/熟悉质量管理,产品安全和风险管理

- procedure & standards understanding (ISO9001, ISO13485, QSR, etc.)/程序和标准的理解

What else do I need to know?

- With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness

Contact

- If you want to know more Siemens job opportunities, please be free to log in our career website www.careers.siemens.com.cn 如需了解更多西门子职位信息，请登录西门子招贤纳士网站www.careers.siemens.com.cn

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西门子磁共振园 —— 为中国，且为世界

2002年7月，西门子（深圳）磁共振有限公司在西门子磁共振园在正式成立，它座落于深圳高新技术产业园区，是一家专门生产医用磁共振成像系统的高新技术企业。

作为西门子全球一体化磁共振战略的重要组成部分，深圳的西门子磁共振园是在德国爱尔兰根总部之外的研发、生产中心之一。该中心占地约三万平方米，集市场推广、研发、生产、技术支持和综合服务于一体，进一步扩大了西门子医疗集团在中国市场研发、生产的能力。

西门子磁共振园拥有近150人的研发团队，约占公司总人数的三分之一,其中90%以上拥有重点大学硕士以上学位。在研发人员的共同努力下，西门子磁共振园自成立以来，已获得近100项技术专利。

西门子磁共振园面向中国和国际市场提供拥有西门子整机技术的1.5T超导磁共振成像系统和0.35T C型开放式永磁磁共振成像系统。西门子磁共振园为全球用户提供一流的技术和服务。

西门子磁共振园的成立是西门子在华业务发展的巨大飞跃，充分表明了西门子在中国开展产品研发的信心。同时，西门子磁共振园也成为西门子全球三大“总部支持中心”(HSC)之一（另外两个分别设在德国和美国），为亚太地区的用户提供技术服务和支持。

地址:深圳南山区科技园中区高新中二道32号西门子磁共振园518057

网址: http://www.siemens.com.cn/ssmr

Email:ssmr-recruit.healthcare@siemens.com