Labeling Project Leader (Medical Devices)

Position Summary

The Labeling Project Leader will lead and execute the label design change project to ensure compliance with ISO14607 : 2024 standards . This individual will oversee the end-to-end labeling change process for the Texas site-covering project planning, cross-functional collaboration, regulatory alignment, and lifecycle labeling portfolio management.

Key Responsibilities

Lead and manage label design change projects and lifecycle labeling activities.

Act as the primary liaison between labeling, quality, regulatory, engineering, and supply chain teams.

Develop and implement project plans , risk assessments, and change management documentation.

Drive cross-functional alignment on scope, regulatory impact, and phase-in / phase-out strategy.

Supervise internal and external team members executing label changes.

Represent labeling in design control, CAPAs, and change management activities.

Ensure all labeling changes meet quality, compliance, and regulatory requirements .

Support multi-generational planning (MGPP) to meet compliance and cost targets.

Required Qualifications

Bachelor's degree in Engineering, Design, or a related discipline.

5+ years of experience in labeling, operations, engineering, regulatory, or quality within a medical device or regulated industry .

Strong project management skills (PMP preferred).

Experience with labeling systems, design control, and change management .

Proficiency in MS Office, MS Project, Visio, and Adobe Illustrator .

Working knowledge of PLM and ERP systems (Windchill, Adaptiv, or JDE preferred).

Familiarity with packaging machinery (Flow Wrap and Cartoning).

Excellent communication, leadership, and stakeholder management skills.

Preferred Skills

Green Belt or Lean Six Sigma certification.

Experience in new product development (NPD) or lifecycle labeling projects.

Strong business and financial acumen .

Experience in medical device labeling compliance and global supply chain processes .

Travel

Up to 5% travel , including occasional international trips (some on short notice).