IT Compliance & Validation Specialist ensuring IT compliance within GMP - regulated environments and performing risk analyses. Join Amapharm's mission and enjoy a range of employee benefits.
About the role
- Quality & Regulatory Affairs Intern supporting maintenance and improvement of QMS at Vara. Collaborating across teams to ensure compliance and enhance healthcare technology.
Responsibilities
- 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
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)
Benefits
- Flexible Work & Team Spirit
- Work at the Merantix AI Campus
- Fair & Competitive Compensation
- A Range of Benefits That Fit Your Life
- Your Growth, Our Priority
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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