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
識別產品需要滿足的強制性技術標準及法規并維護更新
2. Get the country approvals of the target markets
負責目標市場的產品準入
3. Ensue all products accord with different countries regulations and standards
確保所有產品符合各地區的法規和標準
4. Support foreign BLs RA/Sales for local audit and invite public bidding
為國外業務部門的法規事務和市場競標提供法規支持
5. Maintenance of the license for production and operation in the scope of medical device regulations
醫療器械法規內生產/經營許可證的維護
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。
有權力及義務制止任何不滿足關法規和標準的流程及項目。

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 /優秀的技術文檔編輯能力
2. Public relations/良好公共關系能力
3. Medical device product knowledge/醫療器械產品知識
4. ing, audits, reviews, assessments/基準比較,審核,評審和評估方法
5. Perfect english/流利的英文
6. Quality assurance know -how, product safety and risk management/熟悉質量管理,產品安全和風險管理
7. Procedure & standards understanding (ISO9001, ISO13485, QSR, etc.)/程序和標準的理解