Senior Medical Labeling Specialist – Global Impact

Regulatory Jobs; Irvine (CA); On-site; USD 92,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Performance incentives

Benefits package

Job summary

Edwards Lifesciences in Irvine, CA seeks a Senior Labeling Specialist to lead complex labeling projects, collaborate with cross-functional teams, and ensure regulatory compliance across global labeling programs.

You will drive timelines, manage translation work, and mentor labeling staff while aligning with NPD, Clinical, and Sustaining activities in a fast-paced medical device environment.

Qualifications

• Bachelor’s degree and 5+ years in FDA-regulated device/medical/pharma industry.
• Experience in labeling processes and regulatory compliance preferred.
• Strong communication and cross-functional coordination abilities.

Responsibilities

• Collaborate with Business Units to set priorities and workflow milestones for labeling projects.
• Prepare, review, and approve labeling intake documentation and guide the labeling team on accelerated timelines.
• Ensure updates to global labeling standards, procedures, and training plans.
• Collaborate with vendors on translation projects and manage timelines.
• Provide regular reporting on activities, risks, and issue resolution.
• Lead process improvements and Kaizen initiatives to boost efficiency.
• Lead the resolution of SCARs, NCR, and CAPAs with root-cause analysis.
• Coach BU labeling team members and deliver training and playbooks.
• Understand regulatory requirements and ensure compliant labeling implementations.
• Perform other incidental duties as required.

Skills

Project management

Leadership

Communication skills

English fluency

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's Degree with 5 years of related work experience in a device/medical/pharmaceutical FDA regulated industry

Tools

MS Project

MS Office Suite

Job description

Edwards Lifesciences in Irvine, CA seeks a Senior Labeling Specialist to lead complex labeling projects, collaborate with cross-functional teams, and ensure regulatory compliance across global labeling programs.

You will drive timelines, manage translation work, and mentor labeling staff while aligning with NPD, Clinical, and Sustaining activities in a fast-paced medical device environment.