Senior Regulatory Affairs Analyst

7 days ago

Bengaluru, Karnataka, India Siemens Healthineers Full time ₹ 5,00,000 - ₹ 15,00,000 per year

Experience: 5-8 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

Able to work in cross functional teams with good communication & interpersonal skills

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