Labeling Specialist

Labeling Specialist

This role focuses on developing, managing, and maintaining compliant medical device labeling using Bar Tender labeling software within a regulated environment. The Labeling Specialist ensures that all labels meet FDA and other regulatory requirements, supports product lifecycle activities through PLM/QMS platforms, and contributes to high-quality documentation and quality systems management. The position offers the opportunity to work on multiple projects, including supporting a 510(k) submission, while collaborating with a strong quality leadership team in a modern facility with room for professional growth.

Responsibilities:

• Create, configure, and maintain medical device labels using Bar Tender labeling software, ensuring accuracy, consistency, and regulatory compliance.
• Manage the full label lifecycle, including creation, review, approval, release, and controlled changes in alignment with quality and regulatory requirements.
• Work within PLM and QMS platforms, such as Agile or Windchill, to manage labeling documentation, revisions, and approvals in a controlled environment.
• Ensure labeling complies with FDA regulations, including 21 CFR and UDI requirements, and support alignment with EU MDR labeling expectations where applicable.
• Collaborate with quality assurance, regulatory affairs, and document control teams to ensure labeling content and format meet internal standards and external regulations.
• Support quality systems management by maintaining accurate labeling records, documentation, and traceability within established quality processes.
• Contribute to 510(k) project activities by finalizing labeling elements needed to bring products across the regulatory approval finish line.
• Work effectively in a contract or fast-paced environment, handling multiple labeling projects and priorities simultaneously.
• Take ownership of assigned tasks, work independently with minimal supervision, and proactively drive labeling activities to completion.
• Ask clarifying questions and engage with team members when encountering obstacles, ensuring issues are resolved efficiently rather than working in isolation.
• Support continuous improvement of labeling processes, tools, and documentation practices within the quality system.

Essential

Skills:

• 5+ years of experience in medical device labeling or closely related labeling roles.
• Hands-on experience with Bar Tender labeling software as a core tool for label creation and management.
• History in medical device labeling, including understanding of regulatory requirements and label lifecycle management.
• Experience with PLM and QMS platforms, specifically Agile or Windchill, for managing labeling and documentation.
• Knowledge of regulatory compliance for medical devices, including FDA labeling regulations such as 21 CFR and UDI requirements.
• Experience working in a contract or fast-paced environment with multiple concurrent projects.
• Familiarity with quality assurance principles, document control practices, and quality systems management in a regulated setting.
• Ability to work independently, take ownership of tasks, and deliver results with limited supervision.
• Strong communication skills and willingness to ask questions and collaborate with cross-functional teams when needed.

Additional Skills &

Qualifications:

• Experience working with medical device contract manufacturing organizations (CMO).
• Direct experience with Agile or Windchill PLM/QMS platforms beyond basic exposure.
• Exposure to or involvement with regulatory affairs activities related to labeling and submissions.
• Familiarity with EU MDR labeling requirements as a significant advantage.
• Experience supporting 510(k) projects or other regulatory submissions from a labeling perspective.
• Understanding of FDA compliance practices and quality system regulations in the medical device industry.
• Comfort working within structured quality systems and following established procedures and workflows.

Job Type &

Location:

This is a Contract position based out of Maple Grove, MN.

Pay and Benefits:

The pay range for this position is $50.00 - $75.00/hr eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type:

This is a hybrid position in Maple Grove, MN.

Final date to receive applications:

This position is anticipated to close on Jul 29, 2026.