Ada Health GmbH
Quality, Regulatory & Risk Manager(m/w/x)
Full-timeWith HomeofficeExperienced
Berlin
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VAVara
Quality Manager in Regulatory Affairs(m/w/x)
Berlin
Full-timeWith Home OfficeExperienced
AI/ML
Nejo AI Summary
Managing QMS and MDR compliance for AI-powered breast cancer detection software. 2+ years QMS experience in medical device industry, preferably SaMD/AIaMD, essential. Immigration process support.
Requirements
- Higher education degree (PhD, BA, MA)
- Two years of experience managing quality management systems
- Strong communication skills (EN/DE)
- Proven experience in Quality Management within medical device industry, preferably in SaMD/AIaMD
- Strong knowledge of QMS, CAPA, Management Reviews, and risk management (esp. ISO 14971)
- Familiarity with AI/ML validation, software development workflows, and lifecycle management
- Experience with regulatory submissions and audits (MDR, IVDR, MDSAP, FDA SaMD Guidance, IMDRF)
- Certified Auditor for ISO 13485 (additional ISO 27001, ISO 9001 as a plus)
- Experience in cybersecurity, data privacy (GDPR, HIPAA, IEC 81001, IEC 27001)
- Understanding of AI/ML-specific regulatory requirements (e.g., GMLP, EU AI Act)
- Prior experience in startup or scale-up environments
- Fluent in German (minimum B2-level)
Tasks
- Maintain and improve the Quality Management System (QMS)
- Ensure compliance with ISO 13485 and regulatory requirements
- Coordinate updates to key SOPs and processes
- Support internal audits and data privacy initiatives
- Act as the person responsible for regulatory compliance under MDR
- Provide guidance on quality and compliance issues
- Train staff on QMS processes and regulatory best practices
- Prepare for management reviews and assist with SOP management
- Manage internal and external audits for compliance
- Drive continuous improvement initiatives
- Support IT security and related employee training
- Advise and support stakeholders on quality and regulatory matters
- Collaborate with cross-functional teams for compliance throughout the product lifecycle
Work Experience
- 2 - 5 years
Education
- Master's degree
Languages
- German – Business Fluent
Tools & Technologies
- ISO 13485
- GDPR
- HIPAA
- IEC 81001
- IEC 27001
Benefits
Competitive Pay
- Fair & competitive compensation
Flexible Working
- Flexible work
Informal Culture
- Team spirit
Learning & Development
- Personal and professional development
Other Benefits
- Support throughout immigration process
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Vara and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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VAVara
Quality Manager in Regulatory Affairs(m/w/x)
Berlin
Full-timeWith Home OfficeExperienced
AI/ML
Nejo AI Summary
Managing QMS and MDR compliance for AI-powered breast cancer detection software. 2+ years QMS experience in medical device industry, preferably SaMD/AIaMD, essential. Immigration process support.
Requirements
- Higher education degree (PhD, BA, MA)
- Two years of experience managing quality management systems
- Strong communication skills (EN/DE)
- Proven experience in Quality Management within medical device industry, preferably in SaMD/AIaMD
- Strong knowledge of QMS, CAPA, Management Reviews, and risk management (esp. ISO 14971)
- Familiarity with AI/ML validation, software development workflows, and lifecycle management
- Experience with regulatory submissions and audits (MDR, IVDR, MDSAP, FDA SaMD Guidance, IMDRF)
- Certified Auditor for ISO 13485 (additional ISO 27001, ISO 9001 as a plus)
- Experience in cybersecurity, data privacy (GDPR, HIPAA, IEC 81001, IEC 27001)
- Understanding of AI/ML-specific regulatory requirements (e.g., GMLP, EU AI Act)
- Prior experience in startup or scale-up environments
- Fluent in German (minimum B2-level)
Tasks
- Maintain and improve the Quality Management System (QMS)
- Ensure compliance with ISO 13485 and regulatory requirements
- Coordinate updates to key SOPs and processes
- Support internal audits and data privacy initiatives
- Act as the person responsible for regulatory compliance under MDR
- Provide guidance on quality and compliance issues
- Train staff on QMS processes and regulatory best practices
- Prepare for management reviews and assist with SOP management
- Manage internal and external audits for compliance
- Drive continuous improvement initiatives
- Support IT security and related employee training
- Advise and support stakeholders on quality and regulatory matters
- Collaborate with cross-functional teams for compliance throughout the product lifecycle
Work Experience
- 2 - 5 years
Education
- Master's degree
Languages
- German – Business Fluent
Tools & Technologies
- ISO 13485
- GDPR
- HIPAA
- IEC 81001
- IEC 27001
Benefits
Competitive Pay
- Fair & competitive compensation
Flexible Working
- Flexible work
Informal Culture
- Team spirit
Learning & Development
- Personal and professional development
Other Benefits
- Support throughout immigration process
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Vara and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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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