Global Labeling Strategist - Medical Devices & Supply Chain

Edwards; Irvine (CA); Hybrid; USD 74,000 - 104,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA, is seeking a Labeling Specialist to drive labeling activities across Clinical, NPD and Sustaining programs. You will partner with manufacturing operations and sales to define content and formats for labels, IFUs, and implant cards, ensuring quality and regulatory compliance.

The role requires a Bachelor's Degree with 3 years in a device/medical FDA-regulated setting, strong MS Office skills, and excellent communication.

Qualifications

• Bachelor's Degree with 3 years of related work experience in a device/medical/pharmaceutical FDA regulated industry.
• Equivalent experience based on Edwards criteria may be considered.

Responsibilities

• Drive labeling activities and ensure alignment with milestones and quality systems.
• Coordinate labeling changes for Clinical, NPD and Sustaining projects; define content, format and artifacts.
• Review workflows and timelines to meet business strategy and customer expectations.
• Identify and execute labeling change tasks to align with project solutions and deadlines.
• Provide guidance to labeling teams on typical solutions and accelerate timetables for critical projects.
• Develop timetables for new and revised labeling content and formats.
• Coordinate translation activities with vendors and manage timelines.
• Lead process-improvement projects and define gaps, revise wording, and train team members.
• Provide support to resolve SCARs, NCRs, non-conformances and CAPAs using data-driven methods.
• Assist with labeling process playbooks and knowledge transfer to teammates.
• Evaluate risks and identify options to resolve critical path issues.

Skills

MS Office Suite

Written and verbal communication

Leadership and change management

Project management

English proficiency

Attention to detail

Problem solving

Team collaboration

Education

Bachelor's Degree

FDA-regulated industry experience

Job description

Edwards Lifesciences in Irvine, CA, is seeking a Labeling Specialist to drive labeling activities across Clinical, NPD and Sustaining programs. You will partner with manufacturing operations and sales to define content and formats for labels, IFUs, and implant cards, ensuring quality and regulatory compliance.

The role requires a Bachelor's Degree with 3 years in a device/medical FDA-regulated setting, strong MS Office skills, and excellent communication.