Director Complaint Process Operation and Investigations
Core
Strategic and operational leadership for complaint management, investigations, and post-market surveillance in regulated healthcare products.
Role type
Director, Quality Operations & Investigations
Builds
Compliant, scalable complaint quality systems and operational surveillance plans
Domain
Healthcare (Medical Device/Pharmaceutical) + Quality Systems/Regulatory Compliance
Required skills
FDA/ISO 13485/14971 knowledge, complaint handling, CAPA, risk management, team leadership, regulatory reporting, audit readiness, data analytics
Preferred skills
Global team leadership, regulatory inspection leadership, strategic planning, talent development
Technologies
Microsoft Office, data analysis tools
Responsibilities
Lead complaint intake, reviews, investigations, and risk analysis; Ensure compliance with FDA/ISO requirements; Monitor KPIs and quality metrics; Manage team performance and succession planning; Represent operations during audits and inspections; Drive process improvements and post-market surveillance strategies.
Seniority
Director, strategic leadership with hands-on operational oversight