JOB DETAILS

Regulatory Affairs Specialist

CompanySiemens Healthineers
LocationChina
Work ModeOn Site
PostedApril 20, 2026
About The Company
Siemens Healthineers is a leading medtech company with over 125 years of experience. We pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our portfolio, spanning in vitro and in vivo diagnostics to image-guided therapy and cancer care, is crucial for clinical decision-making and treatment pathways. With our strengths in patient twinning, precision therapy, as well as digital, data, and artificial intelligence (AI), we are well positioned to take on the greatest challenges in healthcare. We will continue to build on these strengths to help overcome the world’s most threatening diseases, enable efficient operations, and expand access to care. We are a team of more than 71,000 Healthineers in over 70 countries passionately pushing the boundaries of what is possible in healthcare to help improve the lives of people around the world.
About the Role

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.

Analyzes the requirements and prepares product related regulatory submissions.* Creates quality guidelines and work instructions relevant for maintaining regulatory compliance. * Identifies, analyzes and implements country specific requirements necessary for product related submissions. * Plans and prepares product related submissions with Siemens internal (e.g. Branch Countries) or external organizations according to regulatory requirements. * Performs regulatory projects or acts as a member of the project steering group. * Submits required documentation/information to local authorities or Siemens internal. * Initiates and escalates necessary activities if deviations are identified. * Ensures creation of adequate documentation for audits/inspections. * Performs training within the organization in country specific regulatory requirements, if applicable. * Performs review of promotional material for regulatory compliance according to country specific requirements. * May represent the company in industry associations (Lobbying), if applicable.

Who we are: We are a team of more than 72,000 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.

To find out more about Healthineers’ specific businesses, please visit our company page here.

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

Data Privacy: 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 where you can upload your CV. Setting up a profile also 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. Register here to get started.

Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees.  These scammers may attempt to collect your confidential personal or financial information.  If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.

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

Key Skills
Regulatory AffairsRegulatory ComplianceDocumentationQuality GuidelinesRegulatory SubmissionsAuditingInspection PreparationTrainingPromotional Material ReviewProject ManagementLobbyingMedical Technology
Categories
HealthcareScience & ResearchEngineeringManagement & Leadership
Job Information
📋Core Responsibilities
The Regulatory Affairs Specialist is responsible for preparing product-related regulatory submissions and ensuring compliance with country-specific requirements. They also manage documentation for audits, perform internal training, and review promotional materials for regulatory adherence.
📋Job Type
full time
📊Experience Level
2-5
💼Company Size
50875
📊Visa Sponsorship
No
💼Language
English
🏢Working Hours
40 hours
Apply Now →

You'll be redirected to
the company's application page