Medical Device Labeling Specialist - Cross-Functional

Hologic, Inc.; Marlborough (MA); On-site; USD 66,000 - 103,000; Full time

Job summary

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

You will serve as the Labeling representative on cross-functional teams, partnering with Regulatory, Quality, Marketing, Engineering, and other stakeholders to keep labels, Instructions for Use, and related docs accurate, current, and compliant. We welcome candidates with medical device labeling, document control, or regulated documentation experience who can manage multiple

Qualifications

• 4–6 years of related experience with labeling or documentation.
• Experience with medical device labeling and document control.
• Knowledge of QSR/GMP requirements.
• Ability to work with cross-functional teams.

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 and established structures.
• Coordinate translations and review translations for accuracy.
• Manage multiple labeling and documentation projects simultaneously.
• Track master labeling documents and updates to maintain baselines.
• Drive labeling requirements for new product development, sustaining and remediation projects.
• Follow quality system procedures and regulatory requirements.

Skills

Labeling

QSR/GMP

Cross-functional teams

Print publishing

Document control

Adobe Illustrator

InDesign

Agile PLM

Education

High School diploma

Associate’s degree

Bachelor’s degree

Tools

Adobe Illustrator

InDesign

Job description

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

You will serve as the Labeling representative on cross-functional teams, partnering with Regulatory, Quality, Marketing, Engineering, and other stakeholders to keep labels, Instructions for Use, and related docs accurate, current, and compliant. We welcome candidates with medical device labeling, document control, or regulated documentation experience who can manage multiple