Senior Risk Manager — AI-Driven SaMD & Cloud

Philips; Best; On-site; EUR 78,000 - 130,000; Full time

Job summary

Philips is seeking a Senior Risk Manager for the Azurion Eye program to own and evolve the product risk management strategy across the lifecycle. You will drive AI-enabled SaMD, cloud-based solutions, and connected medical devices with a strong emphasis on safety, quality, and regulatory compliance.

The role requires leading hazard analyses, risk assessments, and safety strategies while collaborating with cross-functional teams and ensuring integration with Agile/DevSecOps processes.

Qualifications

• Master’s degree or PhD in a relevant field.
• At least 8 years in regulated medical device development.
• Extensive experience leading risk management for software-intensive devices.
• Experience with AI-enabled SaMD, cloud-native software, 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, regulatory submissions, audits, and post-market surveillance.
• Excellent written and verbal English communication.

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

AI-enabled SaMD

Cloud-native software

Regulatory submissions

DevSecOps / CI/CD

Stakeholder management

English communication

Education

Master’s degree

PhD

Biomedical Engineering

Software Engineering

Tools

Azure

AWS

Kubernetes

Containerization

CI/CD

Job description

Philips is seeking a Senior Risk Manager for the Azurion Eye program to own and evolve the product risk management strategy across the lifecycle. You will drive AI-enabled SaMD, cloud-based solutions, and connected medical devices with a strong emphasis on safety, quality, and regulatory compliance.

The role requires leading hazard analyses, risk assessments, and safety strategies while collaborating with cross-functional teams and ensuring integration with Agile/DevSecOps processes.