Director - Post Market Quality
Core
Own post-market quality systems and regulatory obligations for an AI-driven non-invasive cardiac test (SaMD), ensuring product performance in the field meets global standards.
Role type
Director, Post-Market Quality (AI SaMD)
Builds
Global post-market surveillance, complaint handling, and adverse event reporting systems for AI-enabled medical devices.
Domain
Medical Technology / AI Software as a Medical Device (SaMD)
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
Post-market surveillance (PMS) expertise, AI/ML algorithm performance monitoring, regulatory compliance (FDA 21 CFR, EU MDR), root cause analysis, team leadership, risk management, CAPA management, stakeholder collaboration
Preferred skills
Experience with AI/ML drift detection, statistical signal detection, managing global regulatory submissions
Technologies
FDA 21 CFR Parts 820/803/806, EU MDR, ISO 13485, ISO 14971, IMDRF terminology, AI/ML tools
Responsibilities
Lead complaint handling unit and product investigations; manage global adverse event reporting (FDA MDR, EU Vigilance); oversee field actions, recalls, and health hazard evaluations; establish real-world performance monitoring for AI functions; lead team development and strategic planning; serve as SME during regulatory inspections
Seniority
Director, strategic leadership & team management
