(Sr.)RA Specialist
SIEMENS AG FWB:SIE, NYSE:SIShanghaiUpdate time: October 27,2020
Job Description



Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.


We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting?


Then come and join our global team as EHS Manager to be responsible for biosafety, chemical and hazardous materials use, hazardous and biological waste management, emergency response, and ergonomics for manufacturing/laboratory environments.


Your tasks and responsibilities:



·        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.


·        Other tasks assigned by the company.


 



To find out more about the specific business, have a look at https://www.healthcare.siemens.com.cn/


Your qualifications and experience:


  • 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.



Our global team:


Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.


Our culture:


Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.


Check our Careers Site at www.healthcare.siemens.com.cn/careers.


As an equal opportunity employer, we welcome applications from individuals with disabilities.


We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here to get started. 


To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.




Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai

Experience Level: Experienced Professional

Job Type: Full-time

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