Staff Specialist, Post Market Quality
Core
Global subject matter expert driving post-market quality activities, field actions, and regulatory compliance for Medication Management Solutions.
Role type
Staff Specialist, Post Market Quality (Senior IC)
Builds
Global field action execution, risk management strategies, and regulatory reporting for MedTech products.
Domain
Medical Technology / Regulatory Quality
Required skills
Post-market quality expertise, risk management, regulatory compliance, field action execution, data analytics, cross-functional influence
Preferred skills
Medical device industry experience, global field action knowledge, CAPA processes, audit readiness, advanced data analytics
Technologies
FDA 806 reporting, KPI dashboards, quality system software
Responsibilities
Lead global field actions (recalls, corrections, advisory notices), develop field action documentation and rationale packages, support regulatory submissions and audit readiness, analyze quality metrics and trends, drive continuous improvement initiatives.
Seniority
Staff, strategic support & technical leadership