Labeling Specialist: Medical Device Documentation

Hologic, Inc.; Louisville (CO); On-site; USD 66,000 - 103,000; Full time

Benefits offered by this job

Annual bonus

Competitive salary

Job summary

Hologic, Inc. is seeking a detail-oriented Labeling Specialist to support labeling activities for GSS product portfolios.

You will join cross-functional teams with Regulatory, Quality, Marketing, and Engineering to ensure labels and Instructions for Use are accurate and compliant. This role requires experience in medical device labeling or regulated documentation, plus the ability to manage multiple projects and coordinate reviews.

Qualifications

• Experience in medical device labeling or regulated documentation.
• Ability to manage multiple labeling projects and reviews.
• Knowledge of document control processes and template usage.

Responsibilities

• Support labeling activities for assigned product portfolios.
• Represent Labeling on cross-functional project teams.
• Develop product labels and Instructions for Use using templates.
• Prepare redlines and coordinate review cycles with stakeholders.
• Track labeling documents and ensure accurate baselines.
• Coordinate translations and verify translations against English source.
• Manage labeling deliverables through lifecycle systems.

Skills

Strong communication

QSR/GMP knowledge

Print publishing/document control

Cross-functional teamwork

Agile/PLM familiarity

Translations coordination

Education

High School diploma

Associate's degree

Bachelor's degree

Tools

Adobe Illustrator

InDesign

Job description

Hologic, Inc. is seeking a detail-oriented Labeling Specialist to support labeling activities for GSS product portfolios.

You will join cross-functional teams with Regulatory, Quality, Marketing, and Engineering to ensure labels and Instructions for Use are accurate and compliant. This role requires experience in medical device labeling or regulated documentation, plus the ability to manage multiple projects and coordinate reviews.