SHDM IVD Sr. RA Specialist
|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.|
|If you are ambitious and change makes you thrive, help transform Siemens Healthineers into a learning organization.|
|Provide regulatory guidance on local product
registration to both BU and local project team.|
Specific responsibilities include:
• Set up overall product registration plan and report registration progress or technical concern to representative departments for earlier aware the situation.
• Work closely with global and local regulatory affairs and other department to advise required documents and prepare regulatory submission professionally, responsible for type testing related issues.
• Work as liaison to local authority, timely deliver all necessary registration materials to authorities and follow up with authority to ensure rapid and timely approval of the product.
• Assess impact of product changes on the statues of registration license.
• Keep achieve of all registration related documents, certificates, reports etc.
• Collect related regulation and standard information, keep update on local trend and policy.
|This position may suit you best, if building learning organizations is your expertise and you have extensive experience with Top Management Learning and Leadership Development.|
• At least 5 years domestic IVD registration experience, preferred experience with quality system, CE or FDA.
• Bachelor degree or above, major in medicine or related.
|Find out more about our business and ambition on Siemens Healthineers, please be free to log in our website.|
|If you want to know more Siemens job opportunities, please be free to log in our career website ：|
|May you wish to discuss any initial questions with our recruitment team: （021）3889 5000|
|Talent Acquisition, Siemens Healthineers|
Job ID: 95240
Organization: Siemens Healthineers
Experience Level: Mid-level Professional
Job Type: Full-time