Senior Manager – Post Market Intelligence, Monitoring & Innovation
Core
Lead a global team to turn post-market data into actionable intelligence for product quality and patient safety in the medical device industry.
Role type
Senior Manager, Post-Market Surveillance & Digital Transformation
Builds
Post-market surveillance plans, reports, PSUR inputs, analytics platforms, dashboards, and AI-enabled solutions.
Domain
Medical Devices / Regulatory Quality / Post-Market Surveillance
Deliverable
production ML models | dashboards & analysis
Required skills
Post-market surveillance, complaint analytics, signal detection, risk-based approaches, ISO 13485, EU MDR, regulatory inspections, team leadership, process transformation, cross-functional partnership.
Preferred skills
Master's degree or MBA, ASQ CQE/CQM/RAC/PMP/Lean Six Sigma, ISO 14971, FDA QSR knowledge.
Technologies
Analytics platforms, dashboards, data pipelines, AI-enabled solutions.
Responsibilities
Lead global operating model for monitoring and signal detection; translate data into risk-based insights for leadership; oversee PSURs and surveillance plans; define technology roadmap with IT and Data; drive automation and continuous improvement; lead cross-functional remediation; represent function in audits and inspections; coach and develop a global multidisciplinary team.
Seniority
Senior, hands-on IC with people leadership