SHL RA Specialist Beijing

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 Sr. Regulation Specialist

  • Work and communicate together with regulatory partner in responsible BU to get all registration documents ready on time according to latest regulation.
  • Communicate with test bodies to arrange the on-site testing and get report on time.
  • Arrange the CFDA submission timely and efficiently.
  • Answer all supplemental question from CMDE appropriately and timely by close communication with technical reviewer and support from BU, to archive product licenses in planned period.
  • Archive all registration documents completely and timely
  • Maintain or develop good working relation with certification or testing body, as well as relevant government department to improve working efficiency
  • Involve in or coordinate activities in product inspection by local authorities.   

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

Your tasks and responsibilities:

Your qualifications and experience:

  • Bachelor degree or above with major in medical/ biological related
  • Above 3 years working experience in medical device or pharmacal industry, include but not limited to product registration, R&D, clinical ect.
  • Highly skill in medical device registration and certification and licensing
  • Excellent in cooperation and work well between intercultural and domestic backgrounds.
  • Highly verbal and written communication skills in English as well as Chinese
  • Leadership experience/skill to coach and motivate team

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.

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.


Job ID: 119076

Organization: Siemens Healthineers

Company: Siemens Healthineers Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

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