Overview
In this role, you will lead risk management for AI-enabled SaMD in imaging, ensuring compliance with medical device standards. You will define verification and validation strategies and align with cross-functional teams to deliver safe, regulatory-compliant products. You’ll address AI-specific risks like performance, bias, cybersecurity, and drift, supporting regulatory submissions and post-market activities. This is a chance to shape risk governance in a diverse, values-driven culture that tackles challenging engineering problems.
Verantwortungsbereiche
- Lead risk management activities for AI SaMD products in compliance with ISO 14971
- Define and oversee verification and validation strategies for AI/ML-based medical software
- Ensure compliance with IEC 62304, ISO 13485, FDA SaMD guidance, EU MDR, and GMLP
- Evaluate AI-specific risks including model performance, bias, cybersecurity, data integrity, and model drift
- Support regulatory submissions, audits, and post-market surveillance
- Collaborate with Engineering, Data Science, Clinical, Quality, and Regulatory teams for safe product releases
Zentrale Anforderungen
- 8+ years in Medical Device Software, Quality, Validation, or Regulatory Compliance
- 3+ years in AI/ML-enabled healthcare solutions focused on CT/MRI/US imaging
- AI/ML Risk Management
- Software Verification & Validation (V&V)
- Medical Device Regulatory Compliance
- Requirements Traceability
- Cybersecurity & Quality Management Systems
- Stakeholder Management and Cross-functional Leadership
- Stakeholder management
- Cross-functional collaboration
- Leadership
- AI/ML Risk Management
- Software Verification & Validation (V&V)
- Medical Device Regulatory Compliance
