Labeling Analyst

Job Description:

Labeling Analyst – Electrophysiology (Med Tech)

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, Track Wise, 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