الوصف الوظيفي
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 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)
?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
