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