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FY22 Campus - SSME CT Regulatory Affair Engineer

Job Description

Responsibilities

Ensure product and process compliance with relevant and international laws and regulations.

Establish and maintain product market clearance and other compulsory certification process.

Responsible for market clearance and other compulsory certificate for new product.

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 unite 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 are fulfilled.

Other tasks assigned by supervisors.


Requirement

Bachelor degree or above.

Major with clinical background is preferred (e.g. Biomedical Engineering)



Founded in 1992, Siemens Shanghai Medical Equipment Ltd. (SSME) is today an important R&D and manufacturing base of Siemens Healthineers covering Computed Tomography (CT), X-Ray products, Mobile C-arms, Digital Health products, Mechatronics products as well as Customer Services. Deeply rooted in China for over 20 years, SSME has been consecutively honored with “High-Tech Enterprise” by Shanghai municipal government,  and is certified as “Enterprises with IP Advantages” by China National Intellectual Administration in 2019. The philosophy of local development with global perspective has guided the company in providing world-class products to healthcare institutions across China and the world with continuous innovation. Located in the heart of Shanghai International Medical Zone with land area over 100,000 m², SSME has grown substantially over the past two decades, starting from a simple assembly works to a fully-fledged R&D and manufacturing base today for Siemens Healthineers globally. SSME commits itself to continuous development in high quality, innovative and affordable medical equipments and solutions to support its customers to fight the most threatening diseases, to raise quality and productivity in healthcare, and to enable healthcare providers to increase value.



Organization: Siemens Healthineers

Company: Siemens Shanghai Medical Equipment Ltd.

Experience Level: Recent College Graduate

Job Type: Full-time

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