Architect – Product Safety & Regulatory Engineering

Job Description Summary

Lead Product Safety, Regulatory Compliance, Risk Management, and Design Controls for GE HealthCare's X-Ray Tube and X-Ray Generator portfolio across the entire product lifecycle. This role provides technical leadership to ensure new and installed-base products meet global safety, regulatory, and quality requirements while supporting product enhancements, design changes, supplier transitions, and lifecycle engineering initiatives. The Architect partners with cross-functional global teams to drive compliant product development, regulatory approvals, and risk-based decision making that enables safe, reliable, and innovative medical imaging solutions.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Key Responsibilities

- Provide technical leadership for Product Safety, Regulatory Compliance, Risk Management, and Design Controls for X-Ray Tubes and X-Ray Generators across new product development and lifecycle engineering activities.

- Evaluate the impact of engineering, supplier, component, and manufacturing changes to ensure continued compliance with global regulatory and product safety requirements.

- Lead product risk management activities, including Hazard Analysis, Risk Assessments, Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA), and Product Safety Reviews.

- Lead regulatory compliance and product certification activities, including support for IEC 60601, ISO 14971, ISO 13485, FDA, EU MDR, NMPA, CDSCO, UL, CSA, ETL, RoHS, REACH, and other applicable regional requirements.

- Drive Product Standards Review Board (PSRB) activities, Country Compliance Notifications (CCN), and regulatory assessments to address evolving global regulatory requirements.

- Review and approve technical documentation including Technical Files, Design History Files (DHF), Device Master Records (DMR), Risk Management Files, product specifications, labeling, user documentation, and compliance records.

- Provide regulatory and product safety oversight throughout the Design Control process, including Design Inputs, Design Outputs, Verification, Validation, Design Transfer, Engineering Change Requests (ECRs), and Engineering Change Orders (ECOs).