Senior Labeling Strategy Lead – Medical Devices

Edwards Lifesciences; Irvine (CA); On-site; USD 92,000 - 130,000; Full time

Benefits offered by this job

Competitive salaries

Performance-based incentives

Benefits programs

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Senior Labeling Specialist to ensure compliant labeling across global products. You will lead cross-functional labeling projects, coordinate content, and drive timelines in a regulated medical-device environment.

You’ll collaborate with manufacturing operations, regulatory, quality, and translations teams, shaping labeling standards, reviewing documents, and delivering accurate labels, IFUs, and implant cards to support patient outcomes.

Qualifications

• Bachelor's degree with 5 years in device/medical FDA regulated industry.
• Strong cross-functional collaboration and communication skills.
• Experience with labeling processes and regulatory compliance.

Responsibilities

• Lead labeling projects, define requirements, and approve content artifacts.
• Coordinate translations and ensure timelines and regulatory compliance.
• Develop labeling standards, SOPs, and process improvements.
• Collaborate with vendors and internal teams to meet schedules.

Skills

MS Office

Project management

English fluency

Communication skills

Education

Bachelor's Degree with 5 years related experience

Tools

MS Project

Job description

Edwards Lifesciences in Irvine, CA is seeking a Senior Labeling Specialist to ensure compliant labeling across global products. You will lead cross-functional labeling projects, coordinate content, and drive timelines in a regulated medical-device environment.

You’ll collaborate with manufacturing operations, regulatory, quality, and translations teams, shaping labeling standards, reviewing documents, and delivering accurate labels, IFUs, and implant cards to support patient outcomes.