Senior Manager, Global Process, Systems & Center of Excellence
Core
Lead the Global Process, Systems & Center of Excellence team to manage postmarket surveillance, complaint management, device vigilance, regulatory reporting, and pharmacovigilance processes to ensure regulatory compliance and standardization across Medline's product portfolios.
Role type
Senior Manager, Global Process & Systems
Builds
Global postmarket surveillance processes, complaint/AE IT system governance, and standardized regulatory reporting frameworks
Domain
Medical Devices / Regulatory Affairs / Quality Management Systems
Required skills
Global process governance, postmarket surveillance, complaint management, device vigilance, regulatory reporting, pharmacovigilance, FDA/ISO 13485/MDSAP/EU MDR compliance, cross-functional integration, inspection readiness, team leadership, budget management
Preferred skills
System implementation and integration, global process harmonization, acquisition integration, advanced Excel/Word
Technologies
Electronic complaint/AE/Quality Management Systems, FDA 483 response tools
Responsibilities
Manage development and continuous improvement of global postmarket processes; Lead Center of Excellence for process standardization and harmonization; Oversee complaint/AE IT system governance and change management; Partner with cross-functional teams (Quality, Regulatory, IT) for global process integration; Lead inspection readiness and support regulatory audits; Manage team hiring, performance reviews, and training; Establish governance mechanisms for process and system changes.
Seniority
Senior Manager, people management and strategic oversight