Senior Risk Manager Azurion Eye - AI, cloud, Sa(N)MD
Core
Own and evolve product risk management strategy for AI-enabled, cloud-based, and connected medical solutions across the complete product lifecycle.
Role type
Senior Risk Manager (Medical Devices & AI)
Builds
AI-enabled SaMD, SaNMD, cloud-native software, and connected medical devices
Domain
Healthcare / Medical Devices / AI & Cloud
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Product risk management strategy, hazard analysis, benefit-risk assessment, software risk analysis, AI risk assessment, safety strategy definition, regulatory compliance (ISO 14971, IEC 62304, ISO 13485, FDA QMSR, EU MDR), cross-functional leadership, Agile/DevSecOps integration, post-market surveillance support
Preferred skills
MLOps, computer vision, foundation models, large language models, AI governance, Azure/AWS, Kubernetes, DevSecOps, DICOM/HL7/FHIR interoperability
Technologies
Azure, AWS, Kubernetes, CI/CD pipelines
Responsibilities
Lead product risk management activities from concept to post-market surveillance, Develop and maintain Product Risk Management File, Facilitate cross-functional risk workshops, Integrate risk management into Agile and DevSecOps practices, Coach development teams on product safety culture, Support regulatory submissions and audits
Seniority
Senior, hands-on IC