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Intern in Quality & Regulatory Affairs(m/w/x)
QMS documentation and audit preparation for AI-powered breast cancer detection software. Master's or PhD program enrollment required. Flexible work arrangements.
Requirements
- Enrollment in Master’s or PhD programme
- Foundational understanding of quality management
- Strong English communication skills
- Structured and detail-oriented work approach
- Interest in healthcare technology
- Exposure to ISO 13485 or MDR
- Familiarity with document management systems
- Interest in AI/ML healthcare applications
- Basic understanding of GDPR
- Prior startup or scale-up experience
- Fluency in German
Tasks
- Update Standard Operating Procedures
- Prepare materials for management reviews
- Monitor QMS documentation for compliance
- Apply risk-based quality thinking
- Assist with internal audit preparation
- Compile evidence packages for audits
- Research and summarize regulatory updates
- Support IT security awareness activities
- Maintain data privacy compliance records
- Collaborate with cross-functional teams
- Prepare reports for internal stakeholders
Education
- Currently in higher education
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- ISO 13485
- EU MDR
- SaMD
- AI
- Medical Device concepts
- Document management systems
- Quality tools
- AI/ML
- GDPR
- Cybersecurity
Benefits
Competitive Pay
- Fair and competitive compensation
Flexible Working
- Flexible work
Team Events
- Regular get-togethers
- Offsites
- Team events
Startup Environment
- Merantix AI Campus access
Other Benefits
- Monthly perks
- Personal and professional development
Healthcare & Fitness
- Urban Sports Club subsidies
Corporate Discounts
- Over 100 discounts
Mentorship & Coaching
- Regular development talks
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Intern in Quality & Regulatory Affairs(m/w/x)
QMS documentation and audit preparation for AI-powered breast cancer detection software. Master's or PhD program enrollment required. Flexible work arrangements.
Requirements
- Enrollment in Master’s or PhD programme
- Foundational understanding of quality management
- Strong English communication skills
- Structured and detail-oriented work approach
- Interest in healthcare technology
- Exposure to ISO 13485 or MDR
- Familiarity with document management systems
- Interest in AI/ML healthcare applications
- Basic understanding of GDPR
- Prior startup or scale-up experience
- Fluency in German
Tasks
- Update Standard Operating Procedures
- Prepare materials for management reviews
- Monitor QMS documentation for compliance
- Apply risk-based quality thinking
- Assist with internal audit preparation
- Compile evidence packages for audits
- Research and summarize regulatory updates
- Support IT security awareness activities
- Maintain data privacy compliance records
- Collaborate with cross-functional teams
- Prepare reports for internal stakeholders
Education
- Currently in higher education
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- ISO 13485
- EU MDR
- SaMD
- AI
- Medical Device concepts
- Document management systems
- Quality tools
- AI/ML
- GDPR
- Cybersecurity
Benefits
Competitive Pay
- Fair and competitive compensation
Flexible Working
- Flexible work
Team Events
- Regular get-togethers
- Offsites
- Team events
Startup Environment
- Merantix AI Campus access
Other Benefits
- Monthly perks
- Personal and professional development
Healthcare & Fitness
- Urban Sports Club subsidies
Corporate Discounts
- Over 100 discounts
Mentorship & Coaching
- Regular development talks
About the Company
Vara
Industry
Healthcare
Description
The company develops AI-powered software for breast cancer detection, enhancing early screening and improving women's health.
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