Intern in Quality & Regulatory Affairs

About the role

As a Quality & Regulatory Affairs Intern, you will support the maintenance and continuous improvement of Vara's Quality Management System (QMS). Working closely with the Quality Manager and cross-functional teams, you will gain hands-on experience with ISO 13485, EU MDR, and Software as a Medical Device (SaMD) compliance in a fast-moving, mission-driven environment.

What you'll do

• 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
• 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)
• Collaborate with engineering, clinical, and operations teams to understand how quality requirements apply across the product lifecycle

What you'll need

• 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

What they offer

• Flexible work arrangement - remote or at Berlin office
• Work at the Merantix AI Campus in Berlin's AI scene
• Fair and competitive compensation
• Monthly perks including Urban Sports Club subsidies and 100+ discounts
• Personal and professional development with regular development talks
• Regular team events, get-togethers, and offsites