SHL QT Sr. Regulatory Affairs 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.
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.
Support market research on planned government and competition activities
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.
- Bachelor degree or above with major in medical/ biological related
- Above 3 years in regulatory affairs of active medical device, angiography, X-ray image system filed is priority, can extend to other active medical device if the rich RA experience.
- Experience in active medical device industry, include but not limited to product registration, R&D, clinical etc.
- 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
- Able to work under pressure
Job ID: 98991
Organization: Siemens Healthineers
Experience Level: Experienced Professional
Job Type: Full-time