Product Labeling Specialist - Hybrid (Fraser, MI)

Healthmark, A Getinge company was founded in 1969, employs over 300 people and is a growing company. We strive to provide customers with quality products and support services in a timely and effective manner.

Full Time

Monday - Friday

This is a hybrid role. After training, 3-4 days in office (Fraser, MI) with 1-2 days remote.

Job Overview

The Product Labeling Specialist is responsible for leading the end-to-end development of product labeling while supporting broader marketing initiatives as needed. This role will collaborate with cross-functional teams-including Product Management, Quality, Regulatory, Engineering, Clinical Affairs, and Marketing-to gather accurate information and translate it into clear, compliant, and user-friendly labeling. In addition to managing instructions for use (IFUs), packaging, inserts, and contribute to special marketing projects, such as brochures, educational collateral, or event support materials.

Job Responsibilities and Essential Duties:

Labeling & Compliance

• Own the full product labeling lifecycle, from content development through version control and final approval.
• Gather and synthesize input from Product Management, Clinical Affairs, Regulatory Affairs, Quality, and Engineering teams.
• Create, revise, and maintain IFUs, product packaging labels, inserts, and related documentation.
• Ensure all labeling adheres to regulatory requirements (e.g., FDA, EU MDR) and internal brand standards.
• Manage version control and documentation through internal systems and workflows.
• Support audit preparation and responses related to labeling processes and documentation.

Cross-Functional Coordination

• Serve as a liaison between departments to ensure labeling content is accurate, complete, and aligned across functions.
• Lead or participate in meetings to ensure timely input and alignment on labeling deliverables.
• Help define and improve labeling processes, templates, and workflows for efficiency and consistency.

Additional Marketing Support

• Assist in the development or editing of marketing collateral such as brochures, product sheets, or educational tools.
• Provide support for marketing campaigns, product launches, and events as needed.
• Ensure consistency of messaging and branding across labeling and promotional content.

Required Knowledge, Skills and Abilities:

• Bachelor's degree in a related field (Life Sciences, Communications, Regulatory Affairs, Marketing, or similar).
• Excellent written communication and editing skills with the ability to distill complex information.
• Organized, detail-oriented, and comfortable managing multiple concurrent projects.
• Strong collaboration and interpersonal skills; able to engage technical and creative stakeholders alike.
• Proficient in Microsoft Office; experience with Adobe InDesign or labeling/document control systems is a plus.

Preferred Qualifications:

• 2-5 years of experience in product labeling, technical writing, regulatory documentation, or related marketing role.
• Experience in the healthcare, life sciences, or medical device industry.
• Familiarity with medical device labeling requirements and industry regulations preferred.
• Familiarity with FDA, ISO, or EU MDR labeling requirements.
• Knowledge of documentation systems (e.g., MasterControl, Agile, Windchill).
• Visual communication skills or design literacy is a plus.

#LI-AL1