Regulatory Affairs Manager

Job Description

Experience: 8-10 years  

? 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

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