Labeling Specialist

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

We are looking for a detail-oriented Labeling Specialist to support labeling activities for assigned GSS product portfolios. In this role, you will serve as the Labeling representative on cross-functional project teams and partner closely with Regulatory, Quality, Marketing, Engineering, and other stakeholders to ensure product labels, Instructions for Use, and related documentation remain accurate, current, and compliant.

This is a great opportunity for someone with experience in medical device labeling, document control, print publishing, or regulated product documentation who enjoys managing multiple projects, coordinating reviews, and improving processes. We are open to the following locations: CO, DE, MA, or SD

Key Responsibilities

• Support labeling activities for assigned GSS product portfolios.
• Represent Labeling on cross-functional product and project teams.
• Help drive labeling requirements for new product development, sustaining, and remediation projects.
• Develop product labels and Instructions for Use using corporate templates and established document structures.
• Prepare redlines for labeling changes and coordinate stakeholder review and approval cycles.
• Track master labeling documents and updates to maintain accurate portfolio baselines.
• Support label verification activities to confirm accuracy, consistency, and compliance before release.
• Manage labeling deliverables through Agile or other product lifecycle management systems.
• Coordinate translation activities with internal teams and external translation vendors.
• Review translations against English source content for formatting and numerical accuracy.
• Gather supporting documentation inputs from cross-functional teams for change orders.
• Manage multiple labeling and documentation projects at the same time.
• Prioritize deliverables, manage urgent requests, and communicate timelines, risks, and status clearly.
• Contribute to process improvements, work instructions, style guides, templates, knowledge base topics, and department procedures.
• Follow applicable procedures and quality system requirements.

Required Qualifications

• High School diploma with 4-6 years of related experience, or
• Associate's degree with 2-4 years of related experience, or
• Bachelor's degree with 0-2 years of related experience.
• Basic knowledge of QSR/GMP requirements.
• Basic experience with print publishing, design, or document control programs.
• Strong communication skills and ability to work with cross-functional teams.
• Ability to manage multiple documentation projects and shifting priorities.

Preferred Qualifications

• 4-6 years of related experience.
• Proficiency with Adobe Illustrator and InDesign.
• Familiarity with Agile Product Lifecycle Management.
• Prior experience with surgical or interventional medical device labeling.
• Experience supporting a product portfolio end-to-end, from label creation through lifecycle maintenance.
• Experience coordinating documentation review cycles, change control, and translations.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you. The annualized base salary range for this role is $65,900 - $103,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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