Support the maintenance and continuous improvement of Vara’s Quality Management System (QMS)
Assist in reviewing and updating Standard Operating Procedures (SOPs) under the guidance of the Quality Manager
Support the preparation of materials for management reviews
Help monitor QMS process documentation for completeness and compliance with ISO 13485
Learn and apply structured quality thinking (risk-based approach, CAPA, process awareness) in day-to-day tasks
Shadow and assist during internal audit preparation activities
Help compile evidence packages and document findings for audit readiness
Research regulatory updates (MDR, EU AI Act, ISO standards) and summarise implications for the team
Support IT security awareness activities tied to the QMS (e.g., documentation, training materials)
Assist in maintaining records relevant to data privacy compliance (GDPR)
Collaborate with engineering, clinical, and operations teams to understand how quality requirements apply across the product lifecycle
Prepare summaries, reports, and presentations on quality and regulatory topics for internal stakeholders

Currently enrolled in a Master’s or PhD programme in a relevant field (e.g., biomedical engineering, life sciences, regulatory affairs, health informatics, or similar)
Foundational understanding of quality management principles or regulatory frameworks (gained through coursework, projects, or a prior internship)
Strong written and verbal communication skills in English
Structured, detail-oriented approach to work and documentation
Intellectual curiosity and genuine interest in healthcare technology and patient safety
Nice to have: Exposure to ISO 13485, EU MDR, or SaMD/AI as a Medical Device concepts — through university coursework or a prior internship
Familiarity with document management systems or quality tools
Interest in AI/ML applications in healthcare or understanding of AI/ML-specific regulatory requirements (e.g., GMLP, EU AI Act)
Basic understanding of data privacy fundamentals (GDPR) or cybersecurity
Prior experience in a startup or scale-up environment
Fluent in German (EN/DE)

Quality & Regulatory Affairs Intern

Key skills