Quality Manager in Regulatory Affairs (f/m/d)

We're a company that aims to make breast cancer screening more effective and accessible through AI-powered software. As a Quality Manager in Regulatory Affairs, you'll be responsible for maintaining and improving our Quality Management System, ensuring compliance with ISO 13485 and regulatory requirements, and providing guidance to employees on quality and compliance issues.

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 (4+ years)
• 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)

Benefits

• Flexible Work & Team Spirit
• Work at the Merantix AI Campus
• Fair & Competitive Compensation
• A Range of Benefits That Fit Your Life