Labeling Engineer II: Compliance, Packaging & Innovation

Integer Holdings Corporation; Plano (TX); Remote; USD 70,000 - 102,000; Full time

Job summary

Integer Holdings Corporation in Plano, TX seeks a labeling specialist to manage regulatory labeling deliverables. You will prepare and control labels and Instructions for Use, updating documents through the product life cycle, and coordinating changes to meet FDA and QMS requirements.

You will collaborate with cross-functional teams to validate labeling, manage translations, and maintain UDI databases while ensuring accuracy and traceability across projects.

Qualifications

• Bachelor's degree in a related field or 3+ years of GMP/FDA/Change Control experience.
• Strong written and oral communication skills and attention to detail.
• Ability to work in a team environment and understand regulatory labeling landscape.

Responsibilities

• Adheres to FDA regulations, QMS, safety and environmental requirements.
• Plans, coordinates labeling updates and change controls for labeling documents.
• Prepares, creates, and controls labels and Instructions for Use through product life cycle.
• Reviews labeling documents for accuracy and consistent formatting.
• Maintains UDI databases and supports labeling translations and validation plans.

Skills

Communication

Detail-oriented

Organization

Teamwork

Regulatory labeling

Education

Bachelor's degree in related field

3+ years GMP/FDA/Change Control experience

Tools

MS Office

Adobe InDesign

Adobe Illustrator

Labeling software

Job description

Integer Holdings Corporation in Plano, TX seeks a labeling specialist to manage regulatory labeling deliverables. You will prepare and control labels and Instructions for Use, updating documents through the product life cycle, and coordinating changes to meet FDA and QMS requirements.

You will collaborate with cross-functional teams to validate labeling, manage translations, and maintain UDI databases while ensuring accuracy and traceability across projects.