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SSME XP Regulatory Affairs Officer

Job Description

Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.

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?


Mission/Position

Headline: Ensure SSME products and process complying with relevant international and notional standards and regulations.

Take responsible for product registration.

Areas of 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 relavant organization to set up a network to impove 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.

•Regulation knowledge sharing in team.

•Other tasks assigned by supervisors.

Dimension of Function/Volume: Collection of relevant international and national standards and regulations. Implementation of relevant standards and regulations.



Organization: Siemens Healthineers

Company: Siemens Shanghai Medical Equipment Ltd.

Experience Level: Experienced Professional

Full / Part time: Full-time

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