Labeling Analyst

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 improvements and support SOP updates Qualifications & Experience Bachelor’s degree in Life Sciences, Engineering, or related field 3–7+ years in medical device labeling, regulatory, or quality Experience with cardiovascular / electrophysiology devices preferred Key Skills Knowledge of FDA, EU MDR, and UDI labeling requirements Strong technical writing and documentation skills Familiarity with QMS, change control, and document systems Strong attention to detail and ability to manage multiple projects Preferred Experience with EP devices (catheters, mapping/ablation systems) Familiarity with PLM systems (SAP, TrackWise, Agile) Knowledge of global labeling standards and eIFU Success Metrics Compliance with regulatory requirements (no critical findings) On-time delivery of labeling updates Reduced labeling errors and rework