We at Siemens Healthineers™ are committed to helping healthcare providers globally to succeed in today’s dynamic environment. We are inspired to transform the way things are done – because we want what is best for our people, our customers and ultimately the health of mankind. While we are invested in engineering excellence – leading-edge medical technologies and services, we don’t stop there. We’re also deeply invested in our 46.000 people with the hearts of pioneers and minds of engineers, highly committed and connected in this industry. And as we strive to shape the future of healthcare, our overall success will depend on our ability to continuously reinvent ourselves.

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 country approvals of the target markets
负责目标市场的产品准入
3. Ensue all products accord with different countries regulations and standards
确保所有产品符合各地区的法规和标准
4. Support foreign BLs RA/Sales for local audit and invite public bidding
为国外业务部门的法规事务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
医疗器械法规内生产/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。
有权力及义务制止任何不满足关法规和标准的流程及项目。

Regualtory affair
--Get the country approvals of the target markets, which includes preparing the necessary documents with cooresponding experts (e.g. tehcnical file), arranging type test and clinical uation, coordinating the audit, and so on.
--Remain and understand current domestic and international medical device regulations and standards
--Support Foreign BLs RA/Sales for local audit and public bidding, provide necessary documents and licenses to regional RA
--Ensue all products compliance with different countries or regions regulations
--Maintenance of the license for production and operation of medical devices, which are under the medical devices regulations.
--Incorporate the results into quality report

What do I need to qualify for this job?
1. Perfect technical writer /优秀的技术文档编辑能力
2. Public relations/良好公共关系能力
3. Medical device product knowledge/医疗器械产品知识
4. ing, audits, reviews, assessments/基准比较,审核,评审和评估方法
5. Perfect english/流利的英文
6. Quality assurance know -how, product safety and risk management/熟悉质量管理,产品安全和风险管理
7. Procedure & standards understanding (ISO9001, ISO13485, QSR, etc.)/程序和标准的理解