Senior Risk Manager, AI SaMD & Cloud EyeCare

Philips Iberica SAU; Netherlands; Hybrid; EUR 78,000 - 130,000; Full time

Benefits offered by this job

Bonus 3%

Hybrid work arrangement

Office-based collaboration 3 days/week

Job summary

Philips Iberica SAU seeks a Senior Risk Manager Azurion Eye to lead and evolve product risk management across the full lifecycle of AI-enabled, cloud-based medical solutions. You will ensure compliance with safety, quality, and regulatory standards while steering risk activities from concept to post-market surveillance.

The role emphasizes leading hazard analyses, AI risk assessments, and integrating risk practices into Agile and CI/CD workflows, with cross-functional collaboration across

Qualifications

• Lead product risk management activities from early concept and architecture through development, regulatory submission, post-market surveillance, and continuous software releases.
• Develop and maintain the Product Risk Management File in accordance with ISO 14971 and Philips QMS requirements.
• Lead hazard analyses, benefit-risk assessments, software risk analyses, and AI risk assessments.
• Define safety strategies for AI-enabled SaMD, SaNMD, cloud-native software, connected medical devices, and distributed services.
• Facilitate cross-functional risk workshops with Engineering, Clinical, Quality, Regulatory Affairs, and Product Management.
• Integrate risk management into Agile, DevSecOps, CI/CD, and software lifecycle practices.
• Use complaint data, software telemetry, clinical feedback, and AI performance monitoring to support product safety decisions.
• Support regulatory submissions, audits, CAPA investigations, field actions, and post-market surveillance.
• Coach development teams and promote a strong product safety culture.

Responsibilities

• Lead product risk management activities from early concept and architecture through development, regulatory submission, post-market surveillance, and continuous software releases.
• Develop and maintain the Product Risk Management File in accordance with ISO 14971 and Philips QMS requirements.
• Lead hazard analyses, benefit-risk assessments, software risk analyses, and AI risk assessments.
• Define safety strategies for AI-enabled SaMD, SaNMD, cloud-native software, connected medical devices, and distributed services.
• Facilitate cross-functional risk workshops with Engineering, Clinical, Quality, Regulatory Affairs, and Product Management.
• Integrate risk management into Agile, DevSecOps, CI/CD, and software lifecycle practices.
• Use complaint data, software telemetry, clinical feedback, and AI performance monitoring to support product safety decisions.
• Support regulatory submissions, audits, CAPA investigations, field actions, and post-market surveillance.
• Coach development teams and promote a strong product safety culture.

Skills

Risk management

ISO 14971

AI risk assessments

Cross-functional leadership

Regulatory submissions

Education

Master’s or PhD in Biomedical/Systems/Software Engineering or Computer Science

Tools

Azure

AWS

Kubernetes

CI/CD

DevSecOps

FHIR

Job description

Philips Iberica SAU seeks a Senior Risk Manager Azurion Eye to lead and evolve product risk management across the full lifecycle of AI-enabled, cloud-based medical solutions. You will ensure compliance with safety, quality, and regulatory standards while steering risk activities from concept to post-market surveillance.

The role emphasizes leading hazard analyses, AI risk assessments, and integrating risk practices into Agile and CI/CD workflows, with cross-functional collaboration across