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SSME MP Senior 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?


Ensure SSME products and process complying with relevant standards and regulations. Get the country approvals of China market.

Responsibilities:

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.

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

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.

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

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.

Responsible for coordination of factory inspection from third party.

Regulation knowledge sharing in team.

Other tasks assigned by supervisors.

Requirements:

At least 5 years’ experience in Regulatory affairs.

Bachelor degree or above.



Our global team:

We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

Our culture:

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

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. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here to get started. 

To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.



Organization: Siemens Healthineers

Company: Siemens Shanghai Medical Equipment Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

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