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 have 3-5 years of experience in regulatory affairs for Software as Medical Device, SaaS, and/or cloud deployment.
- 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).
- 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.
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.