Senior Risk Manager Azurion Eye - AI, cloud, Sa(N)MD

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

Job Title

Job Description

Senior Risk Manager Azurion Eye - AI, cloud, Sa(N)MD

As Senior Risk Manager within the Azurion Eye program, you own and continuously evolve the product risk management strategy across the complete product lifecycle. You ensure that AI-enabled, cloud-based, and connected medical solutions are developed and maintained in line with applicable safety, quality, and regulatory requirements.

Your role:

• 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.

You're the right fit if:

• A Master’s or PhD in Biomedical Engineering, Systems Engineering, Software Engineering, Computer Science, or a related field.

• At least 8 years of experience in regulated medical device development.

• Extensive experience leading risk management for software-intensive medical devices.

• Experience with AI-enabled SaMD, connected healthcare systems, 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.

• Strong stakeholder management skills and the ability to influence cross-functional engineering teams.

• Excellent written and verbal communication skills in English

Nice to have

• Experience with MLOps, computer vision, foundation models, or large language models.

• Knowledge of AI performance, bias, explainability, model drift, human oversight, and AI governance.

• Experience with Azure or AWS, Kubernetes, containerized applications, DevSecOps, and continuous software delivery.

• Knowledge of connected-device interoperability, including DICOM, HL7, and FHIR.

• Familiarity with FDA Good Machine Learning Practice and ISO/IEC 42001.

Compensation & benefits

Doing meaningful work should come with fair, transparent rewards. The base salary range for this role is€78187–€130312. We determine pay within the range using objective factors, like the skills the role requires, your relevant experience and the responsibility you'll have in this role, alongside internal equity and local market considerations.This role is eligible for3% bonus,with your rewards linked toKPIs/company results.We’ll share the full approach with you during the interview process, so you can make a clear, informed decision.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.

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