Remote Labeling Engineer II Regulatory & Documentation

Integer Holdings Corporation; United States; Remote; USD 70,000 - 102,000; Full time

Benefits offered by this job

Medical benefits

401(k) with company matching

Paid time off

Job summary

Integer Holdings Corporation is seeking a labeling specialist to manage the creation and control of product labels and Instructions for Use throughout the lifecycle. You will ensure formatting consistency, implement Change Controls, and maintain UDI data in FDA GUDID and EUDAMED, coordinating with cross-functional teams.

Ideal candidates have a bachelor’s degree or 3+ years of GMP/FDA experience, strong communication, and proficiency with MS Office and Adobe InDesign/Illustrator.

Qualifications

• Bachelor’s degree in a related field or 3+ years of GMP/FDA experience.
• Strong written and oral communication skills; attention to detail.

Responsibilities

• Plans, schedules, conducts, and coordinates labeling projects of moderate scope.
• Prepares, creates, and controls labels and Instructions for Use.
• Tracks and maintains labeling documents and revision control.
• Implements Change Control Requests for labeling updates.
• Supports UDI databases (FDA GUDID, EUDAMED).
• Collaborates with cross-functional teams to ensure labeling deliverables are on track.
• Provides labeling translations and validates packaging and labeling per regulatory requirements.

Skills

Strong written communication

Oral communication

Attention to detail

MS Office

Adobe InDesign

Adobe Illustrator

Label creation software

Regulatory labeling landscape

Education

Bachelor’s degree or 3+ years GMP/FDA experience

Tools

Adobe InDesign

Adobe Illustrator

Job description

Integer Holdings Corporation is seeking a labeling specialist to manage the creation and control of product labels and Instructions for Use throughout the lifecycle. You will ensure formatting consistency, implement Change Controls, and maintain UDI data in FDA GUDID and EUDAMED, coordinating with cross-functional teams.

Ideal candidates have a bachelor’s degree or 3+ years of GMP/FDA experience, strong communication, and proficiency with MS Office and Adobe InDesign/Illustrator.