Job Description: Labeling Analyst – Electrophysiology (MedTech)
Job Summary
Supports the development, review, and lifecycle management of labeling for electrophysiology (EP) medical devices (e.g., catheters, mapping and ablation systems). Ensures all labeling (IFU, packaging, and digital) is accurate, compliant with global regulations, and aligned to clinical use and product design. Works cross-functionally with Regulatory, Quality, R&D, and Manufacturing.
Key Responsibilities
Develop and maintain labeling content (IFU, labels, manuals)
Ensure compliance with FDA, EU MDR, UDI, and global standards
Manage labeling changes through change control (ECO/CAPA)
Support audit readiness and maintain version-controlled documentation
Collaborate cross-functionally to drive timely labeling approvals
Review artwork, translations, barcodes, and labeling data
Ensure EP-specific labeling clearly communicates device use, safety, sterility, and risks
Identify process imp...