Regulatory Labeling Specialist — Medical Devices

Hologic, Inc.; Newark (DE); On-site; USD 73,000 - 115,000; Full time

Job summary

Hologic, Inc. is seeking a Regulatory Operations & Labeling Specialist to support labeling and regulatory operations across GSS product portfolios.

You will serve as the Labeling representative on cross-functional teams and partner with Regulatory Affairs, Quality, Marketing, Engineering, and other stakeholders to keep labels, IFUs, and related documentation accurate and compliant. You will provide operational support for regulatory submissions, document control, regulatory systems management,

Qualifications

• High School Diploma with 4+ years of related experience, or an Associate Degree with 2+ years, or a Bachelor's Degree with 0-2 years.
• Basic knowledge of QSR and GMP.
• Experience with document control, print publishing, or regulated documentation processes.
• Strong written and verbal communication skills and ability to collaborate with cross-functional teams.
• Ability to manage multiple projects and changing priorities in a fast-paced environment.

Responsibilities

• Support labeling activities for assigned product portfolios.
• Represent Labeling on cross-functional product and project teams.
• Drive labeling requirements for new product development, sustaining engineering, and remediation projects.
• Create and maintain product labels and Instructions for Use (IFUs) using approved templates and document structures.
• Prepare redlines for labeling changes and coordinate stakeholder review and approval cycles.
• Maintain master labeling documents and portfolio baselines to ensure accuracy and consistency.
• Perform label verification activities to confirm compliance, accuracy, and completeness prior to release.
• Manage labeling deliverables through Agile Product Lifecycle Management (PLM) and other document management systems.
• Coordinate translation activities with internal stakeholders and external translation vendors.
• Review translated content against source documentation for formatting, numerical accuracy, and consistency.
• Gather supporting documentation and cross-functional inputs required for change orders and regulatory submissions.
• Prepare, format, and publish regulatory submissions in accordance with applicable health authority requirements and electronic submission standards.
• Maintain regulatory information management systems, ensuring accurate tracking of registrations, licenses, approvals, and submission status.
• Manage regulatory document control activities, including version control, records management, and audit readiness.
• Support compliance with regulatory databases and establishment registrations, including UDI and health authority portals.
• Provide operational support during audits and inspections by retrieving, organizing, and maintaining regulatory documentation.Facilitate compliant review and approval processes for advertising and promotional materials.
• Coordinate cross-functional review workflows to ensure content is appropriately vetted prior to release.
• Maintain records retention for approved promotional materials and associated review documentation, ensuring audit readiness and compliance.
• Manage multiple labeling, regulatory, and documentation projects simultaneously.
• Prioritize competing deliverables and effectively communicate timelines, risks, and project status.
• Support continuous improvement initiatives, including work instructions, templates, style guides, knowledge management resources, and departmental procedures.
• Ensure compliance with applicable quality system requirements, policies, and procedures.

Skills

Communication skills

Cross-functional collaboration

Project management

Multitasking

Education

Bachelor's degree

Associate degree

High school diploma

Tools

Adobe Illustrator

Adobe InDesign

Agile PLM

Job description

Hologic, Inc. is seeking a Regulatory Operations & Labeling Specialist to support labeling and regulatory operations across GSS product portfolios.

You will serve as the Labeling representative on cross-functional teams and partner with Regulatory Affairs, Quality, Marketing, Engineering, and other stakeholders to keep labels, IFUs, and related documentation accurate and compliant. You will provide operational support for regulatory submissions, document control, regulatory systems management,