Labeling Specialist, Global Medical Device Supply Chain

Edwards Lifesciences; Irvine (CA); On-site; 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 within a global operations and quality framework.

You will partner with manufacturing operations, sales and translation vendors to develop labels, IFUs, implant cards, and related artifacts, while ensuring compliance with FDA regulations and labeling quality systems. A Bachelor's degree and 3 years of related experience are required.

Qualifications

• Bachelor's Degree with 3 years of related work experience in a device/medical FDA regulated industry.
• Experience with labeling, document control, and regulatory standards is preferred.

Responsibilities

• Drive labeling activities to meet business outcomes.
• Define labeling change requests with content, format and artifacts.
• Coordinate with cross-functional teams to meet timelines.
• Ensure compliance with labeling quality systems and track milestones.
• Lead creation and revision of labeling content and formats.
• Coordinate translation projects and manage translation workflows.
• Support process improvements and document training materials.
• Identify risks and assist with critical path issue resolution.
• Address SCARs, NCRs, CAPAs as needed.

Skills

MS Office Suite

Communication skills

Relationship management

Style guides

Change management

Project management

Attention to detail

English proficiency

Education

Bachelor's Degree in related field

Job description

Edwards Lifesciences in Irvine, CA is seeking a Labeling Specialist to drive labeling activities across clinical, NPD and sustaining programs within a global operations and quality framework.

You will partner with manufacturing operations, sales and translation vendors to develop labels, IFUs, implant cards, and related artifacts, while ensuring compliance with FDA regulations and labeling quality systems. A Bachelor's degree and 3 years of related experience are required.