For our Siemens Healthineers Sector in Shanghai, we are looking for a Regulatory compliance engineer.

Mission of Function:
Ensure SSME X-Ray products and process compliance with relevant and international laws and regulations.

What are my responsibilities?
•Ensure SSME X-Ray products and process compliance with relevant and international laws and regulations.
•Responsible for regulatory standard testing such as safety, EMC (IEC60601-1, IEC60601-1-2 etc.)
•Communicate with Government office and Siemens internal relevant organization to set up a network to improve market clearance process
•Cooperate and Coordinate closely with new project team to ensure market clearance and other compulsory certificate process smoothly and efficiently.
•Well communicate with business unit about the progress and status.
•Responsible for coordination of factory inspection from third party.
•Act as consultant internally on product regulatory and ensure regulatory requirements as fulfilled.
•Support imported X-Ray products CFDA testing including test planning and arrangement.

What do I need to qualify for the job?
•Good knowledge on relevant standards and regulations
•Good knowledge on EMC field including testing and troubleshooting
•Experience in Regulatory affairs and networking to authorities
•Strong motivation of self-development
•Good communication with internal and external department,
•Good communication skills with foreigner.