QA/RA Consultant
Core
Lead quality management system (QMS) implementations and regulatory compliance strategies for medical device clients using an AI-powered platform.
Role type
Senior QA/RA Consultant (Medical Device Regulatory Affairs)
Builds
Scalable QMS deployments and automated compliance frameworks for medical device manufacturers
Domain
Medical Device Industry / Regulatory Affairs / Quality Management Systems
Deliverable
production ML models | product features | client delivery
Required skills
QMS setup and deployment, ISO 13485 and Global QMS requirements, eQMS implementation and validation, medical device cybersecurity, regulatory submission requirements, client consulting
Preferred skills
Experience at large medical device companies (Stryker, Medtronic, Boston Scientific), consulting firm background, startup experience (Series A/B), cybersecurity or software validation specialization
Technologies
AI-powered compliance platforms, eQMS systems
Responsibilities
Lead QMS setup and deployment for medical device clients, Own and manage QMS templates and regulatory compliance frameworks, Provide expert consulting on ISO 13485, MDSAP, GxP, and other quality systems standards, Scale operations to support high-growth clients, Develop repeatable QMS deployment processes leveraging AI platform capabilities, Work independently on complex quality assurance projects
Seniority
Senior, hands-on IC with strategic scope