Labeling Specialist: Medical Device Documentation & Compliance

DIRECT SALES, US; Louisville (CO); On-site; USD 66,000 - 103,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

Comprehensive training

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 stay accurate and compliant.

Ideal candidates have experience in medical device labeling, document control, or regulated product documentation and can handle multiple projects, timelines, and process improvements.

Qualifications

• High School diploma or higher with related experience.
• Experience with labeling, document control, or regulated product documentation.
• Ability to manage multiple documentation projects and shifting priorities.

Responsibilities

• Support labeling activities for assigned GSS product portfolios.
• Represent Labeling on cross-functional product and project teams.
• Develop product labels and Instructions for Use using templates.
• Prepare redlines and coordinate stakeholder review cycles.
• Track master labeling documents and updates for portfolio baselines.

Skills

Strong communication

Cross-functional collaboration

Project multitasking

Education

High School diploma with 4-6 years experience

Associate's degree with 2-4 years experience

Bachelor's degree with 0-2 years experience

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 stay accurate and compliant.

Ideal candidates have experience in medical device labeling, document control, or regulated product documentation and can handle multiple projects, timelines, and process improvements.