Technical Leader Regulatory Verification
Core
Lead the organization and execution of product verification for medical devices, ensuring design inputs are achieved and documentation is audit-proof.
Role type
Senior IC technical leader (regulatory verification)
Builds
Verified medical device products and accessories compliant with regulatory standards
Domain
Medical device industry (dialysis machines preferred)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
System verification planning, test strategy definition, test case creation, deviation analysis, regulatory standard interpretation (IEC 60601), risk management, audit documentation, design review coordination
Preferred skills
HD dialysis machine knowledge, QMS standard familiarity (ISO 13485), sample preparation and simulation
Technologies
Microsoft Office suite, testing equipment for medical devices
Responsibilities
Organize and execute product verification, define test strategies, coordinate with external labs, create verification documents, act as independent reviewer for design reviews, manage regulatory approval submissions
Seniority
Senior, hands-on IC