Labeling Specialist

Medical Device Labeling Specialist

Support the creation, maintenance, and management of medical device labeling using Bar Tender software. This role ensures labels meet regulatory, quality, and packaging requirements while partnering with cross-functional teams in a regulated medical device environment.

• Design, update, and maintain medical device labels using Bar Tender.
• Manage label changes through the full lifecycle, including creation, review, approval, and retirement.
• Develop labeling content and associated documentation.
• Partner with Packaging, Regulatory, Quality, and Manufacturing teams to ensure labeling compliance and accuracy.
• Manage labeling records and approvals within PLM/QMS systems.
• Troubleshoot labeling issues and support audits, inspections, and continuous improvement initiatives.
• Ensure compliance with FDA, ISO 13485, and other applicable regulations.

• 4+ years of medical device labeling experience.
• Hands-on experience with Bar Tender labeling software.
• Knowledge of ISO 13485, 21 CFR 820, and medical device labeling requirements.
• Experience with technical documentation, label lifecycle management, and change control processes.
• Familiarity with PLM and QMS systems.
• Strong attention to detail, technical writing, and organizational skills.
• Ability to work independently and collaborate across functions.

• Experience with Agile PLM, Windchill, or similar systems.
• Knowledge of UDI, FDA labeling regulations, and EU MDR requirements.
• Experience in document control and fast-paced medical device environments.
• Strong cross-functional communication and project management skills.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $40.00 - $60.00/hr individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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 fully onsite position in Maple Grove, MN.

Final date to receive applications

This position is anticipated to close on Sep 6, 2026.