Ada Health GmbH
Quality, Regulatory & Risk Manager(m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Berlin
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VAVara
Quality Manager in Regulatory Affairs(m/w/x)
Berlin
Vollzeitmit HomeofficeBerufserfahren
AI/ML
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- 2 - 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
Tools & Technologien
- ISO 13485
- GDPR
- HIPAA
- IEC 81001
- IEC 27001
Benefits
Attraktive Vergütung
- Fair & competitive compensation
Flexibles Arbeiten
- Flexible work
Lockere Unternehmenskultur
- Team spirit
Weiterbildungsangebote
- Personal and professional development
Sonstige Vorteile
- Support throughout immigration process
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Vara erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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VAVara
Quality Manager in Regulatory Affairs(m/w/x)
Berlin
Vollzeitmit HomeofficeBerufserfahren
AI/ML
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- 2 - 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
Tools & Technologien
- ISO 13485
- GDPR
- HIPAA
- IEC 81001
- IEC 27001
Benefits
Attraktive Vergütung
- Fair & competitive compensation
Flexibles Arbeiten
- Flexible work
Lockere Unternehmenskultur
- Team spirit
Weiterbildungsangebote
- Personal and professional development
Sonstige Vorteile
- Support throughout immigration process
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Vara erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Vara
Branche
Healthcare
Beschreibung
The company develops AI-powered software for breast cancer detection, enhancing early screening and improving women's health.
Noch nicht perfekt?
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Vollzeitmit HomeofficeBerufserfahrenBerlin - Flinn.ai
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