Post Market Surveillance Manager (Medical Devices)
Core
Establishing and managing a global Post Market Surveillance (PMS) and Quality Assurance Regulatory Affairs Compliance (QARAC) audit program for medical devices to ensure regulatory compliance and quality system effectiveness.
Role type
Senior IC Post Market Surveillance Manager (Medical Devices)
Builds
Global QARAC Audit program and Global PMS program compliant with FDA, eMDR, and Vigilance standards
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA reporting and compliance for medical devices, managing global audit programs, harmonizing internal audit processes, eMDR and Vigilance reporting, proactive data analysis, team management, continuous improvement methodologies
Preferred skills
Experience with QARA standards, facilitating independent internal auditors, maintaining centralized audit logs, sharing industry best practices
Technologies
eMDR, QARAC, Global Dashboards
Responsibilities
Manage and maintain the Global QARAC Audit program to meet customer and regulatory requirements; Manage and maintain the Global PMS program ensuring compliance with eMDR and Vigilance reporting; Identify and facilitate a team of qualified independent internal QARAC auditors; Conduct proactive data analysis to identify opportunities for improving global quality and compliance systems; Ensure monthly reports on key process metrics are available on the global dashboard
Seniority
Senior, hands-on IC with team management