Regulatory Affairs Manager for AI - based Software Products

Job Description

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.


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?


Then come and join our global team as Regulatory Affairs Manager (m/f/d) for AI-based Software products to achieve market approvals for our Digital Health portfolio.


Your Tasks And Responsibilities


• In coordination with the regional units, you will draw up market access strategies and apply for licenses for AI-aided devices for the Digital Health (DH) business area


• You will provide support to development projects to ensure compliance with regulatory requirements


• You will be responsible for coordinating, carrying out and documenting approval activities and for ensuring that the devices registered comply with the law


• You will be responsible for compliance with internal and external country-specific rules for the approval of medical devices


• You will provide support with the evaluation and approval of product changes and marketing documents


• You will provide support for audits and inspections by external bodies


• You will ensure market access by incorporating regulatory requirements into the processes


• To achieve this, you will work closely with specialist departments at Digital Health and with regional units throughout the world


To find out more about the specific business, have a look at


Your Qualifications And Experience


• You have successfully completed a course of studies in a technical or clinical field, preferably in engineering, medicine, medical engineering or (medical) informatics


• You can offer extensive professional experience in regulatory affairs for Software as Medical Device, SaaS, and/or cloud deployments


• We would also like to hear from you if you already have very sound and extensive professional experience and further qualifications in this field, but do not have a degree


• You have a sound knowledge of international laws, standards and regulations for licensing medical devices, and of the business processes of medical device manufacturers (e.g. MDD/MDR, 21CFR 820; ISO 13485; IEC 62304; IEC 62366; ISO 14971)


• Ideally you have a knowledge of clinical decision support systems and/or the approval of software for medical devices in Europe and the USA


• Your profile also includes a knowledge of regulatory requirements for the clinical evaluation of software for medical devices


• Experience in process or quality management would be an advantage, as well as a knowledge of standards for data exchange between software systems in healthcare (DICOM, HL7 and/or FHIR)


Your Attributes And Skills


• Your personal qualities include a professional approach, skills in planning and organization, and cross-cultural experience


• You also have team and communication skills, initiative, and a structured, target-oriented way of working


• You champion the success of Siemens Healthineers with drive and passion


Our Global Team


Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.


Our Culture


Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.

Organization: Siemens Healthineers

Company: Siemens Healthineers India LLP

Experience Level: Mid-level Professional

Job Type: Full-time

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