Labeling Specialist

Hologic•Louisville, KY

1d•Remote

About The Position

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

Requirements

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.

Nice To Haves

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.

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.