Labeling Specialist

Actalent; Minnesota; On-site; USD 70,000 - 90,000; Full time

Job summary

Actalent seeks a Labeling Specialist in Minnesota to develop, manage, and maintain medical device labeling using BarTender within a regulated environment. You will ensure labels meet regulatory, quality, and packaging requirements while collaborating with cross‑functional teams in a fast-paced medical device organization.

The role emphasizes ISO 13485 and 21 CFR 820 compliance and PLM/QMS usage. The position requires 4+ years in medical device labeling, strong attention to detail, and the

Qualifications

• 4+ years in medical device labeling under ISO 13485 and 21 CFR 820.
• Experience with BarTender labeling software and label design.
• Ability to author labeling content and regulatory documentation.
• Experience with PLM and QMS platforms.
• Familiarity with FDA labeling regulations including UDI.
• Strong written communication and cross-functional collaboration.

Responsibilities

• Design, develop, and maintain medical device labels using BarTender in alignment with regulatory and quality requirements.
• Manage the full label lifecycle from creation to retirement of labeling content and formats.
• Author and update labeling content and related technical documentation.
• Collaborate with packaging engineering, regulatory affairs, QA, and document control to ensure labels meet all regulatory needs.
• Support implementation requirements for labeling with packaging design and manufacturing.
• Ensure labeling activities comply with ISO 13485 and 21 CFR 820.
• Route, track, and control labeling documents in PLM/QMS.
• Troubleshoot labeling issues and coordinate timely resolution with stakeholders.
• Take ownership of labeling projects and work independently with high accuracy.
• Proactively seek clarification when obstacles arise.
• Contribute to continuous improvement of labeling processes and standards.
• Support audits and inspections with labeling documentation.

Skills

BarTender

Medical labeling

ISO 13485

21 CFR 820

PLM/QMS

Windchill

Agile PLM

Documentation

Detail-oriented

Independent work

Tools

Windchill

Agile PLM

QMS platforms

Job description

Job Description

Job Title: Labeling Specialist

Job Description

This role focuses on developing, managing, and maintaining medical device labeling using BarTender labeling software within a regulated environment. The Labeling Specialist ensures all labels meet regulatory, quality, and packaging requirements throughout the label lifecycle, while collaborating with cross-functional teams in a fast-paced, growth-oriented medical device organization.

Responsibilities

• Design, develop, and maintain medical device labels using BarTender labeling software in alignment with regulatory and quality requirements.
• Manage the full label lifecycle, including creation, review, revision, approval, and retirement of labeling content and formats.
• Author and update labeling content and related technical documentation to support medical device products and packaging.
• Collaborate with packaging engineering, regulatory affairs, quality assurance, and document control to ensure labels meet all functional, regulatory, and packaging needs.
• Support implementation requirements for new and existing labels, including integration with packaging design and manufacturing processes.
• Ensure labeling activities comply with medical device quality system standards, including ISO 13485 and 21 CFR 820.
• Use PLM and QMS platforms to route, track, and control labeling documents, changes, and approvals.
• Troubleshoot labeling issues and coordinate timely resolution with relevant stakeholders.
• Take ownership of assigned labeling projects and tasks, working independently while ensuring high accuracy and attention to detail.
• Proactively ask questions and seek clarification when encountering obstacles to maintain progress and quality.
• Contribute to continuous improvement of labeling processes, templates, and standards.
• Support audits and inspections by providing labeling documentation and demonstrating compliance with applicable regulations.

Essential Skills

• Hands-on experience with BarTender labeling software, including label design, configuration, and maintenance.
• Experience in medical device labeling, including understanding of regulatory requirements and label lifecycle management.
• Minimum of 4+ years of experience in medical device environments, working under ISO 13485 and 21 CFR 820 quality system requirements.
• Experience in labeling design and technical writing for medical devices, including instructions, warnings, and regulatory content.
• Experience supporting implementation requirements for labeling in coordination with packaging engineering and manufacturing.
• Exposure to packaging engineering, regulatory affairs, packaging design, quality assurance, document control, and labeling software in a regulated context.
• Familiarity with PLM and QMS platforms, with transferable skills from systems such as Agile or Windchill.
• Ability to work independently, take ownership of tasks, and deliver high-quality work with minimal supervision.
• Willingness to ask questions and collaborate with team members when encountering challenges.
• Strong attention to detail and accuracy in documentation and label content.

Additional Skills & Qualifications

• Direct experience with Agile PLM or Windchill systems.
• Experience working in a contract, consulting, or fast-paced project environment.
• Familiarity with FDA labeling regulations, including 21 CFR and Unique Device Identification (UDI) requirements.
• Knowledge of EU Medical Device Regulation (EU MDR) labeling requirements.
• Experience working within a formal document control environment for labeling and technical documentation.
• Strong written communication skills for clear and compliant technical writing.
• Ability to collaborate effectively with cross-functional teams in a medical device setting.

Work Environment

The role is based in a brand-new, modern medical device facility located in the Arber Lakes area, offering a spacious, well-organized environment with significant room for growth and expansion. The workplace emphasizes collaboration across product design, development, manufacturing, regulatory, quality, and packaging functions. The organization focuses on accelerating medical device product development and commercialization, creating a dynamic and fast-paced setting where adaptability and initiative are valued. Work is performed in a professional office and laboratory/manufacturing-adjacent environment that relies heavily on digital tools such as BarTender labeling software and PLM/QMS platforms. The culture encourages ownership, open communication, and proact