Labelling Specialist

Integrated Resources, Inc ( IRI ); Saint Paul (MN); Hybrid; USD 55,000 - 62,000; Full time

Job summary

Integrated Resources, Inc (IRI) invites applications for a hybrid, 12-month W2 contract role in Arden Hills. The position focuses on coordinating and developing labeling artwork for medical devices, ensuring regulatory compliance and efficient collaboration with cross-functional teams.

The role requires 4+ years in labeling, experience with Adobe Creative Suite, and a background in regulated industries. Travel and visa sponsorship are not expected for this assignment.

Qualifications

• 4+ years of professional labeling experience.
• Experience with Adobe Creative Suite.
• Experience in medical device or regulated industry.
• Experience with quality systems and change control.
• Strong attention to detail and ability to manage multiple priorities.

Responsibilities

• Coordinate desktop publishing and labeling artwork using Adobe Creative Suite.
• Create labeling data and formats within GLS.
• Support content for Instructions for Use (IFU) manuals.
• Coordinate translations for labeling and literature.
• Manage content changes to protect schedules and consistency.
• Create new packaging components and implement changes.
• Maintain labeling graphics filing systems.
• Ensure compliance with labeling procedures and quality systems.
• Support Change Request activities for labeling and literature release.
• Communicate with outside vendors on packaging artwork and proofing.
• Monitor project activities and address schedule/quality issues.
• Foster consistency across labeling.
• Identify opportunities to improve labeling processes.

Skills

Adobe Creative Suite

Attention to detail

Cross-functional collaboration

Graphic design principles

Tools

Adobe InDesign

Adobe Photoshop

Adobe Illustrator

Global Labeling System (GLS)

Job description

Schedule: Hybrid - 3 days onsite in Arden Hills; onsite days are flexible

Duration: 12 months W2 contract with high possibility of extension based on performance and depending on business needs

Max Pay Rate: $40-$45/hr on W2

Work Authorization

Applicants must be authorized to work in the U.S. without visa sponsorship now or in the future. The Client is unable to consider candidates who require sponsorship.

Position Overview

• Responsible for coordinating and developing packaging and labeling artwork for new and existing medical device products related to acquisitions, including supporting review, approval, and implementation activities.
• Collaborates with cross-functional stakeholders to design, update, and maintain product labels and labeling content, ensuring accuracy, visual effectiveness, cost efficiency, and compliance with applicable regulatory requirements, industry standards, and company policies.

Key Responsibilities

• Coordinate and perform desktop publishing and labeling artwork generation using graphic design skills and knowledge of graphic design principles with computer graphics software, including Adobe InDesign, Adobe Photoshop, and Adobe Illustrator.
• Coordinate and create labeling data and formats within the Global Labeling System (GLS).
• Act as a resource for Acquisition product development teams in creating content for Instructions for Use (IFU) manuals.
• Coordinate translations for labeling and literature using translation vendors.
• Manage content changes and mitigate impacts to schedules and consistency by partnering with teams to ensure accuracy and completeness.
• Create new packaging components and implement changes to existing packaging components based on pre-existing formats and designs.
• Maintain Labeling Graphics filing systems, including paper-based and electronic records.
• Leverage expertise with labeling procedures, requirements, and quality systems to ensure all deliverables are compliant and error-free.
• Support review and Change Request activities for the approval and release of labeling, literature, and other packaging components.
• Communicate with outside vendors regarding packaging artwork and proofing.
• Monitor project activities and work with functional and project management teams to address issues that could negatively impact schedule or quality.
• Foster and improve content consistency across labeling.
• Identify and recommend opportunities to improve labeling processes and procedures.
• Quality Systems Duties & Responsibilities
• Build Quality into all aspects of work by maintaining compliance with all quality requirements.

Required Qualifications

• Experience using Adobe Creative Suite.
• Minimum 4 years of professional labeling experience.
• Experience working within quality systems and change control processes.
• Strong attention to detail and ability to manage multiple priorities in a deadline-driven environment.
• Experience working in the medical device industry or another highly regulated industry.
• Experience with medical electrical equipment or similar capital equipment.
• Ability to collaborate effectively with cross-functional partners, including: