Global Labeling Specialist: Medical Devices

Regulatory Jobs; Irvine (CA); On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

Competitive compensation

Performance-based incentives

Benefits package

Job summary

Edwards Lifesciences is seeking a Labeling Specialist in California to drive labeling activities within Global Operations & Quality, partnering with manufacturing operations and sales. You will manage labeling changes, content, and translations, ensuring compliance with regulatory standards and project deadlines.

The role requires a Bachelor’s degree with 3 years in a device/medical/pharmaceutical FDA-regulated setting, strong English skills, and proven project leadership.

Qualifications

• Bachelor's Degree with 3 years of related work experience in a device/medical/pharmaceutical FDA regulated industry or equivalent.
• Experience with labeling change control and documentation development.
• Ability to read, comprehend, write, and speak English.

Responsibilities

• Drive labeling activities and align with business outcomes.
• Define labeling requirements for complex change packages.
• Coordinate with cross-functional teams to meet milestones and timelines.
• Lead labeling content creation and translation projects.
• Support CAPAs and quality events in labeling processes.

Skills

MS Office Suite

Written and verbal communication

Leadership and influence

Project management

Problem-solving

Attention to detail

English proficiency

Team collaboration

Education

Bachelor's Degree in related field

Job description

Edwards Lifesciences is seeking a Labeling Specialist in California to drive labeling activities within Global Operations & Quality, partnering with manufacturing operations and sales. You will manage labeling changes, content, and translations, ensuring compliance with regulatory standards and project deadlines.

The role requires a Bachelor’s degree with 3 years in a device/medical/pharmaceutical FDA-regulated setting, strong English skills, and proven project leadership.