Qualifications:
>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 (6-10 years) in regulatory affairs for:
*Medical Devices (preferably radiology products eg MR, CT)
*SaMD, SaaS, and/or cloud deployments
>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, IEC 62570, IEC 60601(60601-2-33 would be an added advantage)
>Experience in process or quality management would be an advantage
Your Attributes And Skills:
>You are business-fluent in English, enabling you to operate successfully in our international context; knowledge of German would be an advantage
>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
Roles and Responsibilities:
>Ensure the medical device products comply with the regulations of the regions where it is planned to be marketed and sold.
>Maintaining a good understanding of new and existing regulations, standards and guidances that may impact their organization's products and processes.
>Collect, collate and evaluate product specific information in order to create and update the dossiers that must be submitted for new product licenses and license renewals.
>Prepare submissions for regulatory registration and renewals
>Maintaining data and files on country registrations for future reference, particularly in the event of an audit by a regulatory agency
>Preparing for and supporting internal, regulatory, and third-party audits as necessary
>Collaborate with the project teams and explaining regulatory requirements, procedures, and policies to all employees and stakeholders as necessary.
>Able to work in cross functional teams with good communication & interpersonal skills