Regulatory Compliance Manager II
Core
Manages quality assurance execution across application delivery and regulated quality services to ensure consistent quality outcomes and compliance with defined requirements.
Role type
Senior IC Regulatory Compliance Manager
Builds
Regulated quality services and application delivery with consistent quality outcomes
Domain
Healthcare logistics and regulated operational services
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
QA standards implementation, test strategy and traceability, continuous testing platform administration, defect and incident workflow management, controlled documentation authoring, audit and inspection execution, deviation investigations, CAPA management, change control, product disposition decisioning
Preferred skills
ASQ certified quality auditor, certified professional in healthcare quality, QMS certification
Responsibilities
Implement QA standards, procedures, metrics, and reporting; validate requirements coverage through test strategy and release readiness; operate continuous testing platforms; standardize defect and incident workflows; author and maintain controlled documentation for audit readiness; execute client and regulator audit and inspection activities; administer regulated quality processes including deviation investigations, CAPA, complaints, change control, and product disposition
Seniority
Senior, hands-on IC with management capacity