Sr Spec Quality Process
Core
Design, integrate, and maintain global quality processes for complaint management, investigations, device vigilance, and regulatory reporting across medical devices, pharmaceuticals, and biologics.
Role type
Senior Quality Process Specialist (Regulatory & Vigilance)
Builds
Global complaint management and regulatory reporting frameworks, IT system workflows, and coding standards.
Domain
Healthcare / Medical Devices / Pharmaceuticals / Regulatory Compliance
Required skills
Quality Systems (QSR), FDA regulations, ISO standards, Post-market surveillance, Device vigilance, Regulatory reporting, Process governance, Data analysis, IT system configuration, Change management
Preferred skills
SAP, ETQ Reliance, Multi-jurisdictional regulatory experience, Acquisition integration, Global process harmonization
Technologies
SAP, ETQ Reliance, Microsoft Suite, MS Visio, MS Project, Minitab
Responsibilities
Administer global complaint management and regulatory reporting processes; Analyze quality data to track performance and compliance; Support development and testing of complaint/AE IT systems; Collaborate with cross-functional teams to deploy quality processes; Support regulatory audits and inspections; Provide training and coaching on quality standards.
Seniority
Senior, hands-on IC