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

Role Overview

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.

What You Will Do

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.

Why It Might Be a Fit

You have at least 8 years of experience in regulated medical device development and extensive experience leading risk management for software-intensive medical devices. Experience with AI-enabled SaMD, connected healthcare systems, cloud-native software, and distributed architectures is required. Strong knowledge of ISO 14971, IEC 62304, IEC 82304-1, ISO 13485, IEC 81001-5-1, FDA QMSR, and EU MDR is essential. The role offers a base salary range of €78187–€130312 and is eligible for a 3% bonus.

Requirements

• 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

Benefits

• 3% bonus