Working Student – Regulatory Affairs, Quality Management

Role Overview

• Quality management system (ISO 13485 / ISO 27001)
• Support in maintaining and continuously improving the QMS
• Development and (partly) automation of reporting and data structures, e.g., for the Management Review
• Participation in document management (SOPs, templates, records) as well as in the change management process
• Support in preparing internal audits and in tracking CAPAs/nonconformities (depending on process maturity)
• Support in building, implementing and documenting the Information Security Management System (ISMS) (policies, processes, evidence)
• If needed: creation of training materials/videos for colleagues
• Contribution to the creation and maintenance of technical documentation (e.g., EU MDR)
• Research and clear summarization of regulatory requirements, standards and guidance
• Support with document checks and traceability (e.g., Technical File, risk documentation, labeling/IFU)

Requirements

• You are currently enrolled at a university (e.g., biomedical engineering, medical technology, quality/regulatory, computer science/IT security, industrial engineering or similar)
• Structured, detail-oriented working style and a strong commitment to quality in documentation
• Interest in standards, norms and compliance (ISO 13485, MDR; first exposure is a plus)
• Confident use of MS Office; ideally experience with Jira/Confluence or QMS/DMS tools