Senior Risk Manager, AI SaMD & Cloud Medical Devices

Philips; Best; Hybrid; EUR 78,000 - 130,000; Full time

Job summary

Philips is seeking a Senior Risk Manager for the Azurion Eye program to own the product risk management strategy across the full lifecycle, ensuring AI-enabled, cloud-based, and connected medical solutions meet safety, quality, and regulatory requirements.

You will lead hazard analyses, safety strategies for AI SaMD/SaNMD, integrate risk management into Agile/DevSecOps, collaborate with cross-functional teams, and support regulatory submissions and post-market surveillance.

Qualifications

• 8+ years in regulated medical device development.
• Experience leading risk management for software-intensive devices.
• Experience with AI-enabled SaMD, cloud-based systems, and distributed architectures.
• Strong knowledge of ISO 14971, IEC 62304, IEC 82304-1, ISO 13485, IEC 81001-5-1, FDA QMSR, and EU MDR.
• Experience with cybersecurity risk management and regulatory submissions.

Responsibilities

• Lead product risk management from concept through post-market surveillance and continuous software releases.
• Develop and maintain the Product Risk Management File per ISO 14971 and Philips QMS.
• Lead 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 with Engineering, Clinical, Quality, Regulatory Affairs, and Product Management.
• Integrate risk management into Agile, DevSecOps, CI/CD, and software lifecycle practices.
• Use data and AI performance monitoring to support safety decisions.
• Support regulatory submissions, audits, CAPA investigations, field actions, and surveillance.
• Coach development teams to promote a strong product safety culture.

Skills

Risk management

ISO 14971

AI risk assessment

Regulated devices

Education

Master’s/PhD in a related field

Tools

Azure

AWS

Kubernetes

Job description

Philips is seeking a Senior Risk Manager for the Azurion Eye program to own the product risk management strategy across the full lifecycle, ensuring AI-enabled, cloud-based, and connected medical solutions meet safety, quality, and regulatory requirements.

You will lead hazard analyses, safety strategies for AI SaMD/SaNMD, integrate risk management into Agile/DevSecOps, collaborate with cross-functional teams, and support regulatory submissions and post-market surveillance.