QA/RA Consultant
Core
Lead 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
Repeatable QMS deployment processes and automated compliance frameworks for medical device clients.
Domain
Medical Device Industry / Regulatory Affairs / Quality Management Systems
Deliverable
production ML models | product features | client delivery
Required skills
QMS setup and implementation, ISO 13485, MDSAP, GxP, eQMS validation, medical device cybersecurity, regulatory submission, client consulting
Preferred skills
Experience at large medical device companies (Stryker, Medtronic, Boston Scientific), consulting firm background, startup experience (Series A/B), cybersecurity/usability/software validation specialization, AI in regulatory affairs
Technologies
AI-powered compliance platform, eQMS systems
Responsibilities
Lead QMS setup and deployment, manage QMS templates and compliance frameworks, provide expert consulting on quality standards, scale operations for high-growth clients, develop repeatable deployment processes, shape regulatory affairs through product development, work independently on complex projects, ensure customer success
Seniority
Senior, hands-on IC with strategic consulting scope