Head of Global Medical Device Safety & Post-Market Surveillance
Core
Lead global strategy, governance, and compliance for Medical Device Safety, Vigilance, and Post-Market Surveillance (PMS) to protect patient safety across international markets.
Role type
Senior leadership (Head of Global Medical Device Safety & PMS)
Builds
Global safety governance frameworks, regulatory compliance systems, and risk mitigation processes for medical devices
Domain
Medical Technology / Optics / Regulatory Affairs
Required skills
Global product safety strategy, regulatory compliance (EU MDR, US FDA, MDSAP), incident assessment and reporting, risk management, post-market surveillance data analytics, crisis management, team leadership, stakeholder engagement
Preferred skills
Digital transformation, AI-enabled solutions, clinical evidence integration, talent development, multilingual communication
Technologies
EU MDR, US FDA, MDSAP, AI-enabled analytics, CAPA systems
Responsibilities
Define global PMS strategy and governance; ensure regulatory compliance across markets; oversee incident reporting and trend analysis; lead risk identification and mitigation; drive digital transformation in data collection; manage field safety corrective actions; lead the global safety organization and training; engage with regulatory authorities
Seniority
Senior, hands-on IC with strategic leadership