Medical Device Labeling Specialist — Cross-Functional Lead

Hologic, Inc.; San Diego (CA); 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 for GSS product portfolios.

You will serve as the labeling representative on cross-functional teams with Regulatory, Quality, Marketing, and Engineering to ensure labels, Instructions for Use, and related documents stay accurate, current, and compliant. This role requires experience in medical device labeling or regulated product documentation, ability to manage multiple projects, and coordination of reviews.

Qualifications

• High school diploma or higher with relevant experience as listed.
• Knowledge of QSR/GMP requirements is basic but essential.
• Experience in print publishing, design, or document control.
• Ability to manage multiple labeling projects and shifting priorities.

Responsibilities

• Support labeling activities for assigned GSS product portfolios.
• Represent Labeling on cross-functional product and project teams.
• Drive labeling requirements for new product development and remediation projects.
• Develop product labels and Instructions for Use using templates.
• Prepare redlines and coordinate stakeholder reviews and approvals.
• Track master labeling documents and update portfolio baselines.
• Support label verification for accuracy and compliance before release.
• Coordinate translations with internal teams or vendors.
• Review translations against English source for accuracy.
• Manage labeling deliverables through lifecycle systems.
• Prioritize deliverables and communicate timelines and risks.

Skills

Strong communication

Cross-functional teamwork

Project/document management

Education

Bachelor’s degree with 0–2 years of related experience

Associate’s degree with 2–4 years of related experience

High School diploma with 4–6 years of related experience

Tools

Adobe Illustrator

InDesign

Agile PLM

Job description

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

You will serve as the labeling representative on cross-functional teams with Regulatory, Quality, Marketing, and Engineering to ensure labels, Instructions for Use, and related documents stay accurate, current, and compliant. This role requires experience in medical device labeling or regulated product documentation, ability to manage multiple projects, and coordination of reviews.