GE HealthCare
AI Regulatory Engineer
Job Description
**Job Description Summary**
We are seeking a proactive and detail-oriented AI Regulatory Engineer to ensure that AI-based clinical features for ultrasound systems comply with evolving global regulatory requirements—particularly FDA regulations for AI-enabled medical devices.
This role is critical as AI has become a highly regulated domain, requiring specialized regulatory strategies, risk management approaches, and lifecycle governance. The AI Regulatory Engineer will work closely with AI engineering, clinical, quality, product management, and regulatory affairs teams to define and execute the correct AI regulatory and submission strategy across the full product lifecycle.
**Job Description**
**Key Responsibilities**
**AI Regulatory Strategy & Compliance**
• Interpret and apply regulatory frameworks and guidance for **AI-enabled medical devices** , including FDA, EU MDR/IVDR, and global regulations.
• Define and drive **AI regu...
We are seeking a proactive and detail-oriented AI Regulatory Engineer to ensure that AI-based clinical features for ultrasound systems comply with evolving global regulatory requirements—particularly FDA regulations for AI-enabled medical devices.
This role is critical as AI has become a highly regulated domain, requiring specialized regulatory strategies, risk management approaches, and lifecycle governance. The AI Regulatory Engineer will work closely with AI engineering, clinical, quality, product management, and regulatory affairs teams to define and execute the correct AI regulatory and submission strategy across the full product lifecycle.
**Job Description**
**Key Responsibilities**
**AI Regulatory Strategy & Compliance**
• Interpret and apply regulatory frameworks and guidance for **AI-enabled medical devices** , including FDA, EU MDR/IVDR, and global regulations.
• Define and drive **AI regu...