Architect – Product Safety & Regulatory Engineering
Core
Lead Product Safety, Regulatory Compliance, Risk Management, and Design Controls for X-Ray Tube and X-Ray Generator portfolios across the entire product lifecycle.
Role type
Architect – Product Safety & Regulatory Engineering
Builds
Compliant medical imaging solutions (X-Ray Tubes and Generators) for global markets
Domain
Medical Device / Medical Imaging / Regulatory Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Product Safety, Regulatory Compliance, Risk Management, Design Controls, Hazard Analysis, Risk Assessments, DFMEA, PFMEA, Regulatory Certifications (IEC 60601, ISO 14971, ISO 13485, FDA, EU MDR), Technical Documentation Review, Design Transfer, Engineering Change Management, EMI/EMC Compliance, Supplier Quality, Lifecycle Engineering
Preferred skills
Systems Engineering Mindset, Cross-functional Leadership, Complex Medical Device Experience, Continuous Improvement
Technologies
IEC 60601, ISO 14971, ISO 13485, FDA, EU MDR, NMPA, CDSCO, UL, CSA, ETL, RoHS, REACH
Responsibilities
Provide technical leadership for Product Safety, Regulatory Compliance, Risk Management, and Design Controls; Evaluate impact of engineering and manufacturing changes on compliance; Lead product risk management activities including Hazard Analysis and DFMEA/PFMEA; Drive regulatory compliance and certification activities; Review and approve technical documentation including Design History Files and Risk Management Files; Provide oversight throughout the Design Control process; Collaborate with Engineering, Quality, and Regulatory teams to resolve compliance issues; Support internal and external audits.
Seniority
Senior, hands-on IC