Labeling Specialist

Job Description:

This role focuses on developing, managing, and maintaining compliant medical device labeling using BarTender 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 BarTender 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 BarTender labeling software as a core tool for label creation and management.
• Background 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.

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

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)

This is a hybrid position in Maple Grove,MN.

This position is anticipated to close on Jun 12, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $50 - $75