Job Description

Edwards Lifesciences seeks a Labeling Specialist to manage labeling activities and regulatory change requests for cardiovascular medical devices across global markets. The role involves coordinating cross-functional labeling solutions, overseeing document development, and driving process improvements within a quality management system.

Responsibilities

• Drive labeling change request activities and define requirements for clinical, NPD, and sustaining labeling packages
• Review and approve labeling intake documentation, establishing timelines and coordination across teams
• Coordinate translation projects with vendors and manage translation workflow to meet deadlines
• Lead process improvement initiatives and support corrective actions, SCARs, NCRs, and CAPAs
• Provide training and knowledge transfer on labeling processes and maintain documentation playbooks

Requirements

• Bachelor's degree with 3 years of FDA-regulated device/medical/pharmaceutical industry experience or equivalent
• Proficiency with Microsoft Office Suite and strong written and verbal communication skills
• Moderate understanding of medical device regulations, standards, and documentation development
• Project management and change control experience in regulated environments
• Problem-solving, organizational, and critical thinking skills with attention to detail
• Ability to work effectively within quality management and change control processes

Compensation: $74,000 to $104,000 base (California)

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