Shanghai, Shanghai Shi
47 days ago
SSME MP Regulatory Affairs Officer

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Your role:

Clinical affairs including SSME product clinical application support, maintain SSME customer relationship, collect customer feedback on SSME products, support clinical related issues for SSME products & projects.

Responsibilities:

1. Get the country approvals of China market, which includes creating a project plan, preparing the necessary documents with corresponding experts (e.g. product standard, user manuals etc. ), arranging type test and clinical evaluation, submitting application, and so on.

2. Monitoring the development and internal implement of domestic and international technical regulations and standards in order to effectively support our business interests.

3. Identify and monitor the mandatory technical standards and regulations that our products need to be fulfill and keep them up to date and follow up the implementation and compliance.

4. Maintenance of the license for production in the scope of medical device regulations

5. Cooperate and coordinate closely with authority, third party and Siemens internal relevant organization to ensure market clearance and other compulsory certificate process smoothly and efficiently.

6. Responsible for coordination of factory inspection from third party.

7. Regulation knowledge sharing in team.

8. IVD equipment registration experience preferred.

9. Other tasks assigned by supervisors.

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

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

As an equal opportunity employer, we welcome applications from individuals with disabilities.

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. Please create a profile within our talent community and subscribe to personalized job alert that will keep you posted about new opportunities.



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