Senior AI SaMD Risk Manager — Cloud & Regulatory Leadership

Philips International; Northern (KY); Hybrid; USD 91,000 - 151,000; Full time

Benefits offered by this job

3% bonus

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 full lifecycle, ensuring AI-enabled, cloud-based and connected medical solutions meet safety and regulatory requirements.

You will lead hazard analyses and risk assessments, define safety strategies for SaMD/SaNMD, drive cross-functional risk workshops, and integrate risk management into Agile/DevSecOps practices, with strong English communication.

Qualifications

• Regulated medical device development experience (8+ years).
• Experience leading risk management for software-intensive medical devices.
• Proficiency with ISO 14971, IEC 62304, ISO 13485, and FDA QMSR.

Responsibilities

• Lead hazard analyses and risk assessments across product lifecycle.
• Coordinate cross-functional risk workshops with Engineering, Quality, Regulatory.
• Support regulatory submissions and post-market surveillance.

Skills

Risk management

Regulatory submissions

Stakeholder management

English communication

AI risk assessment

Education

Master's/PhD in Biomedical Eng

Tools

Azure/AWS

Kubernetes

CI/CD pipelines

DevSecOps

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 full lifecycle, ensuring AI-enabled, cloud-based and connected medical solutions meet safety and regulatory requirements.

You will lead hazard analyses and risk assessments, define safety strategies for SaMD/SaNMD, drive cross-functional risk workshops, and integrate risk management into Agile/DevSecOps practices, with strong English communication.