Senior Risk Manager – AI, Cloud & SaMD for Azurion Eye

About the role

As Senior Risk Manager for the Azurion Eye program, you will own and evolve the product risk management strategy across the full lifecycle of AI‑enabled, cloud‑based medical solutions. You will ensure compliance with safety, quality and regulatory standards while fostering a strong safety culture.

Key responsibilities

• Lead risk management from concept through development, regulatory submission, post‑market surveillance and continuous releases.
• Develop and maintain the Product Risk Management File per ISO 14971 and Philips QMS.
• Conduct hazard analyses, benefit‑risk, software and AI risk assessments.
• Define safety strategies for AI‑enabled SaMD, SaNMD, cloud‑native software and connected devices.
• Facilitate cross‑functional risk workshops and integrate risk into Agile, DevSecOps and CI/CD processes.
• Use complaint data, telemetry, clinical feedback and AI performance monitoring to guide safety decisions.

Required profile

• Master’s or PhD in Biomedical Engineering, Systems Engineering, Software Engineering, Computer Science or related field.
• At least 8 years of experience in regulated medical device development, with a focus on software‑intensive products.
• Strong knowledge of ISO 14971, IEC 62304, FDA QMSR, EU MDR and cybersecurity risk management.
• Excellent stakeholder management and communication skills in English.

Required skills

• AI‑enabled SaMD and SaNMD risk assessment.
• Cloud‑native software development (Azure, AWS, Kubernetes, containerization).
• DevSecOps, CI/CD and MLOps pipelines.
• Computer vision, foundation models and large language models.
• Connected‑device standards (DICOM, HL7, FHIR).

What we offer

• Base salary €78,187 – €130,312 per year, plus a 3 % performance bonus.
• Hybrid work model – at least three days per week on‑site.
• Opportunity to shape safety for cutting‑edge AI medical technologies.