Senior Manager Medical Device Safety & Post-Market Surveillance
Core
Lead global execution, governance, and continuous improvement of the Post-Market Surveillance (PMS) system for medical devices, ensuring compliance with regulations like EU MDR and FDA.
Role type
Senior Manager, Medical Device Safety & Post-Market Surveillance
Builds
Global PMS strategies, surveillance methodologies, signal detection plans, and regulatory reports (PSURs, PMSRs)
Domain
Medical Technology / Regulatory Affairs
Required skills
Global PMS strategy development, EU MDR/FDA regulatory compliance, signal detection, risk assessment, complaint management, CAPA, cross-functional leadership, data analysis
Preferred skills
PMS digitalization, advanced analytics, AI-enabled surveillance, process harmonization
Technologies
EU MDR, FDA, ISO 14971, MDSAP
Responsibilities
Develop global PMS strategy and governance; Lead PMS plans and regulatory reports; Ensure regulatory compliance; Establish data collection and trend monitoring processes; Identify safety risks and recommend mitigation; Integrate findings into risk management and lifecycle decisions; Support investigations and recalls; Drive digital transformation and automation; Develop training programs; Lead cross-functional projects.
Seniority
Senior, hands-on IC with leadership responsibilities