Global Labeling Specialist — Medical Devices

Edwards Lifesciences Gruppe; United States; On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

Competitive salaries

Performance-based incentives

Benefits programs

Job summary

Edwards Lifesciences seeks a Labeling Specialist to join our Global Operations & Quality team in the United States. You will drive labeling activities, partner with Clinical, NPD and Sustaining teams, and ensure quality content for IFUs, labels, and implant cards.

You will define content requirements, manage timelines, and lead translation projects while upholding FDA-regulated standards and patient-focused goals.

Qualifications

• Bachelor's Degree with 3 years of related work experience in a device/medical FDA regulated industry or equivalent
• Strong written and verbal communication, and interpersonal skills
• Experience with labeling, change control, and documentation in a regulated environment

Responsibilities

• Drive labeling activities and business outcomes across Clinical, NPD and Sustaining labeling change requests
• Define labeling content requirements and ensure alignment on format and artifacts (IFUs, Labels, Implant Cards)
• Manage timelines, provide regular status and issues resolution, and assist with translation projects and cross-functional handoffs
• Lead process improvement efforts and maintain labeling playbooks with training content
• Address risks, CAPAs, NCAs and quality events related to labeling within the quality system

Skills

Written & Verbal Communication

Relationship Management

Leadership & Change

Project Management

Attention to detail

Collaboration

Education

Bachelor's Degree

Tools

MS Office Suite

Job description

Edwards Lifesciences seeks a Labeling Specialist to join our Global Operations & Quality team in the United States. You will drive labeling activities, partner with Clinical, NPD and Sustaining teams, and ensure quality content for IFUs, labels, and implant cards.

You will define content requirements, manage timelines, and lead translation projects while upholding FDA-regulated standards and patient-focused goals.