Manager, Clinical Post Market Surveillance
Core
Manages day-to-day compliance with domestic and international regulations for medical device complaint handling, MDR submissions, and physician follow-up at a specific facility.
Role type
Manager, Clinical Post Market Surveillance
Builds
Compliance lifecycle, CAPA System, External Requirements Management System
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Team management, regulatory compliance strategy, CAPA program leadership, audit management, risk-based prioritization, data analysis, stakeholder partnership
Preferred skills
Knowledge of FDA regulations, international regulatory frameworks, quality management systems, strategic planning
Technologies
Quality Management System (QMS), CAPA System, External Requirements Management System
Responsibilities
Lead site's CAPA program and drive continuous improvements; Serve as primary interface with external regulatory bodies and manage inspections; Analyze trends to proactively address regulatory and quality issues; Lead internal and external audits including FDA and notified body audits; Manage staff development, performance feedback, and goal execution.
Seniority
Manager, hands-on leadership