SSME MI Senior Regulatory Affairs Officer

4 months ago


Shanghai, China Siemens Shanghai Medical Equipment Ltd. Full time

Joinus in pioneering breakthroughs in healthcare. For everyone. Everywhere.Sustainably.

Ourinspiring and caring environment forms a global community that celebratesdiversity and individuality. We encourage you to step beyond your comfort zone,offering resources and flexibility to foster your professional and personalgrowth, all while valuing your unique contributions.

Your role:

EnsureSSME products and process complying with relevant international and nationalstandards and regulations. Take responsibility for product registration.

•Ensure product and processcompliance with relevant and international laws and regulations.

•Catch regulations and standardsupdates, to ensure they could be implemented in related SOPs and products.

•Establish and maintain productmarket clearance and other compulsory certification process.

•Responsible for market clearance andother compulsory certificate for new product and transferred product.

•Communicate with government officeand Siemens internal relevant organization to set up a network to improvemarket clearance process.

•Cooperate and coordinate closelywith new project team to ensure market clearance and other compulsorycertificate process smoothly and efficiently.

•Well communicate with business uniteabout the progress and status.

•Responsible for coordination offactory inspection from third party.

•Coordinate cross RA workshop includeglobal RA workshop.

•Regulation knowledge sharing inteam.

•Other tasksassigned by supervisors, i.e. post market RA tasks, and etc.

Your expertise:

​​ At least 5 years experience in Regulatory affairs.

•Be familiar with China andinternational regulations on medical devices in registration and development.

•Experience in R&D projectquality management or clinical evaluation is a plus.

•Goodrelationship with NMPA.

•Good experience for medical devices testing andtechnological requirement is preferred.

Who we are:
We are a team of more than 71,000 highly dedicated Healthineers in more than 70countries. As a leader in medical technology, we constantly push the boundariesto create better outcomes and experiences for patients, no matter where theylive or what health issues they are facing. Our portfolio is crucial forclinical decision-making and treatment pathways.

How we work:
When you join Siemens Healthineers, you become one in a global team ofscientists, clinicians, developers, researchers, professionals, and skilledspecialists, who believe in each individual’s potential to contribute withdiverse ideas. We are from different backgrounds, cultures, religions,political and/or sexual orientations, and work together, to fight the world’smost threatening diseases and enable access to care, united by one purpose: topioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Asan equal opportunity employer, we welcome applications from individuals withdisabilities.

Wecare about your data privacy and take compliance with GDPR as well as otherdata protection legislation seriously. For this reason, we ask you not to sendus your CV or resume by email. Please withinour talent community and subscribe to personalized job alert that will keep youposted about new opportunities.



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