Global Labeling Specialist — Medical Devices

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 74,000 - 104,000; Full time

Job summary

Edwards Lifesciences Gruppe in Irvine, CA, is seeking a dedicated Labeling Specialist to join our Global Operations & Quality team. You will drive labeling activities, collaborate across manufacturing operations and sales, and ensure timely, compliant labeling deliverables for our cardiovascular devices.

The role requires a Bachelor's degree and 3 years of related experience in a regulated medical environment, along with strong communication, project management, and problem-solving skills.

Qualifications

• Bachelor's degree required with 3+ years in a device/medical FDA-regulated setting.
• Strong written and verbal communication and cross-functional collaboration.
• Experience reading and applying labeling standards and change control workflows.

Responsibilities

• Drive labeling activities and project outcomes across cross-functional teams.
• Define labeling change request requirements with design content and artifacts.
• Review workflows to align with labeling quality systems and milestones.
• Coordinate translation projects and manage vendor communications.
• Lead process-improvement initiatives and provide training as needed.
• Resolve SCARs, NCRs and CAPAs; support risk assessment activities.

Skills

Leadership

Problem-solving

Communication skills

Attention to detail

Education

Bachelor's degree

Tools

MS Office Suite

Job description

Edwards Lifesciences Gruppe in Irvine, CA, is seeking a dedicated Labeling Specialist to join our Global Operations & Quality team. You will drive labeling activities, collaborate across manufacturing operations and sales, and ensure timely, compliant labeling deliverables for our cardiovascular devices.

The role requires a Bachelor's degree and 3 years of related experience in a regulated medical environment, along with strong communication, project management, and problem-solving skills.