Regulatory Affairs Manager
SIEMENSBangaloreUpdate time: March 15,2023
Job Description
Experience: 8-10 years 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 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 Organization: Siemens Healthineers Company: Siemens Healthcare Private Limited Experience Level: Experienced Professional Full / Part time: Full-time

Get email alerts for the latest"Regulatory Affairs Manager jobs in Bangalore"