QA/RA Consultant
Core
Lead quality management system implementations and regulatory compliance strategies for medical device clients using an AI-powered compliance platform.
Role type
Senior QA/RA Consultant (Medical Device Regulatory Affairs)
Builds
Scalable QMS deployments and automated compliance frameworks for high-growth medical device clients
Domain
Medical Device Industry / Regulatory Affairs / Quality Management Systems
Deliverable
production ML models
Required skills
Quality Management System (QMS) setup and implementation, ISO 13485, MDSAP, GxP, eQMS validation, Medical device cybersecurity, Regulatory submission requirements, Client consulting, Independent project ownership
Preferred skills
Experience at large medical device companies (Stryker, Medtronic, Boston Scientific), Consulting firm background, Startup experience (Series A/B), Cybersecurity or usability specialization, AI in regulatory affairs