Corrections & Removals Expert
Core
Ensure Corrections & Removals (C&R) processes are clear, consistent, effective, and aligned with regulatory requirements through process ownership, governance, and continuous improvement.
Role type
Senior IC Quality & Regulatory Process Expert (Medical Devices)
Builds
C&R process frameworks, procedures, decision points, and digital/AI tools for process efficiency
Domain
Medical Devices / Regulatory Compliance / Quality Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory mindset, risk-based process design, process mapping, stakeholder management, change request management, AI/digital tool integration, global medical device regulations knowledge
Preferred skills
Experience with FDA, EU MDR, Health Canada requirements, Field Action, Post-Market Surveillance
Technologies
AI tools, digital process management systems
Responsibilities
Design and evaluate C&R processes for regulatory compliance, develop process frameworks and documentation, identify and resolve process gaps and risks, manage C&R process change requests, leverage AI and digital tools for efficiency
Seniority
Senior, hands-on IC
