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(shí)別產(chǎn)品需要滿足的強(qiáng)制性技術(shù)標(biāo)準(zhǔn)及法規(guī)并維護(hù)更新
2. Get the country approvals of the target markets
負(fù)責(zé)目標(biāo)市場的產(chǎn)品準(zhǔn)入
3. Ensue all products accord with different countries regulations and standards
確保所有產(chǎn)品符合各地區(qū)的法規(guī)和標(biāo)準(zhǔn)
4. Support foreign BLs RA/Sales for local audit and invite public bidding
為國外業(yè)務(wù)部門的法規(guī)事務(wù)和市場競標(biāo)提供法規(guī)支持
5. Maintenance of the license for production and operation in the scope of medical device regulations
醫(yī)療器械法規(guī)內(nèi)生產(chǎn)/經(jīng)營許可證的維護(hù)
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(quán)力及義務(wù)制止任何不滿足關(guān)法規(guī)和標(biāo)準(zhǔn)的流程及項(xiàng)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(yōu)秀的技術(shù)文檔編輯能力
2. Public relations/良好公共關(guān)系能力
3. Medical device product knowledge/醫(yī)療器械產(chǎn)品知識(shí)
4. ing, audits, reviews, assessments/基準(zhǔn)比較,審核,評(píng)審和評(píng)估方法
5. Perfect english/流利的英文
6. Quality assurance know -how, product safety and risk management/熟悉質(zhì)量管理,產(chǎn)品安全和風(fēng)險(xiǎn)管理
7. Procedure & standards understanding (ISO9001, ISO13485, QSR, etc.)/程序和標(biāo)準(zhǔn)的理解