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.

This is a unique opportunity to contribute to real regulatory work - not simulated coursework - at a company building technology that directly impacts patient outcomes.

Start Date: 1 April 2026

Duration: 3 - 6 months

Location: Hybrid - Berlin (Merantix AI Campus) & remote within Germany

Level: Graduate intern (Master’s or PhD student)

Team: Regulatory Affairs & Quality

Key Responsibilities

• 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.

• Audits and Compliance

  • 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.

• IT Security

  • Support IT security awareness activities tied to the QMS (e.g., documentation, training materials).

  • Assist in maintaining records relevant to data privacy compliance (GDPR).

• Cross-functional Support

  • 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.

Requirements:

• 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)
  

What You’ll Learn

By the end of your internship, you will have developed practical, CV-ready experience including:

• How a certified QMS operates under ISO 13485 in a real medical device company

• The practical application of EU MDR and SaMD regulatory requirements

• How to navigate CAPA processes, audit preparation, and risk management documentation

• How quality and regulatory work intersect with AI/ML product development

• How a lean, mission-driven health-tech startup operates day-to-day

Flexible Work & Team Spirit

Whether from home or at our Berlin office, you’re free to shape your workday in the way that suits you best. We believe the best ideas come from collaboration, which is why we actively foster team spirit through regular get-togethers, offsites, and team events.

Work at the Merantix AI Campus

Join us at the Merantix AI Campus – the heart of Berlin’s AI scene. Connect with inspiring people, innovative startups, and be part of a community that thrives on creativity and knowledge-sharing.

Fair & Competitive Compensation

We regularly benchmark salaries within the tech and healthcare sectors to ensure that your work is recognized and fairly rewarded.

A Range of Benefits That Fit Your Life

Enjoy monthly perks tailored to your needs – from Urban Sports Club subsidies to over 100 discounts across health, fitness, retail, and travel. Choose the benefits that support and motivate you the most.

Your Growth, Our Priority

Your personal and professional development matters to us. You’ll work on exciting projects and have regular development talks with your leads to help shape your career path and reach your goals.