Labeling Specialist

Actalent; Minneapolis (MN); Hybrid; USD 41,000 - 54,000; Full time

Benefits offered by this job

Hybrid work model

Health benefits

401(k) retirement plan

Life Insurance

Disability insurance

HSA

Job summary

Actalent is seeking a Labeling Specification Specialist in Minneapolis, MN, to create, review, and manage labeling content for medical products. You will coordinate UDI data in QMS Agile and contribute to continuous improvement of labeling processes and quality systems.

This role suits an established individual contributor who works independently on moderately complex projects, collaborates with cross‑functional teams, and ensures labeling meets medical and regulatory requirements globally.

Qualifications

• Experience with medical package labeling content creation and review.
• Experience with UDI data management in QMS Agile or similar systems.
• Strong proofreading skills with attention to detail.
• Experience with quality systems and CAPA activities.
• Knowledge of medical device regulatory labeling requirements.
• Experience supporting regulatory audits for labeling/documentation.
• Professional discipline through education and experience.

Responsibilities

• Create, review, and reproduce text and artwork required for labeling medical products.
• Ensure labeling art, film, and plate proofs comply with US and international requirements.
• Monitor changes in labeling regulations and update content accordingly.
• Review promotional materials to confirm data support and alignment with approved applications.
• Suggest improvements to labeling processes and quality systems for efficiency and compliance.
• Coordinate and maintain UDI data in QMS Agile with accurate data entry.
• Support CAPA, change control, and validation labeling tasks within quality systems.
• Assist with labeling/documentation audits, providing required evidence.
• Deliver and manage labeling projects from design through implementation.
• Collaborate with stakeholders to share status and input for decision making.
• Apply medical device regulatory knowledge to ensure global labeling compliance.
• Mentor entry-level labeling staff and support personnel.
• Recommend system/process improvements for labeling efficiency.
• Set objectives to meet project milestones and broader goals.

Skills

Labeling content

UDI data management

Proofreading

CAPA

Change control

Regulatory knowledge

Audit support

Independence

Communication

Advanced education

Education

University degree in a relevant field

Advanced degree

Tools

QMS Agile

Job description

Job Description

This role focuses on creating, reviewing, and managing labeling content for medical products, ensuring all materials meet medical, legal, and regulatory requirements. The Labeling Specification Specialist supports quality and regulatory compliance by maintaining accurate labeling data, coordinating UDI information in QMS Agile, and contributing to continuous improvement of labeling processes and quality systems. This position suits an established individual contributor who works independently on moderately complex projects and collaborates with cross-functional teams to deliver high‑quality, compliant labeling.

Labeling Specification Specialist

Job Description

This role focuses on creating, reviewing, and managing labeling content for medical products, ensuring all materials meet medical, legal, and regulatory requirements. The Labeling Specification Specialist supports quality and regulatory compliance by maintaining accurate labeling data, coordinating UDI information in QMS Agile, and contributing to continuous improvement of labeling processes and quality systems. This position suits an established individual contributor who works independently on moderately complex projects and collaborates with cross‑functional teams to deliver high‑quality, compliant labeling.

Responsibilities

• Create, review, and reproduce text and artwork required for labeling medical products, ensuring accuracy and completeness.
• Ensure labeling art, film, and plate proofs comply with all applicable medical, legal, and regulatory requirements in the US and abroad.
• Monitor changes in labeling regulations and standards and incorporate updates into labeling content and processes as needed.
• Review promotional and commercial communication materials to confirm they are supported by appropriate data and align with approved applications.
• Monitor, evaluate, and recommend improvements to labeling processes, quality systems, tools, and policies to enhance efficiency and compliance.
• Coordinate and maintain UDI data within QMS Agile, including accurate data entry and ongoing data management.
• Support quality systems activities, including CAPA, change control, and validation‑related labeling tasks.
• Assist with quality and regulatory audit activities related to labeling and documentation, providing required evidence and explanations.
• Deliver and manage assigned labeling projects from design through implementation while adhering to relevant policies and procedures.
• Collaborate with internal stakeholders to share status, requirements, and issues, and gather input to support decision‑making.
• Apply specialized knowledge of medical device regulatory requirements to ensure labeling meets global regulatory expectations.
• Provide guidance and assistance to entry‑level professionals or support staff involved in labeling and quality activities.
• Make recommendations for enhancements to systems and processes to solve problems or improve the effectiveness of the labeling function.
• Set objectives for assigned work to meet project milestones and contribute to broader project goals.

Essential Skills

• Experience with medical package labeling, including creation and review of labeling content for medical products.
• Experience with UDI data management, including data entry and coordination within QMS Agile or similar systems.
• Strong proofreading skills with exceptional attention to detail for reviewing labels and related documentation.
• Previous experience with quality systems and CAPA, including investigation, documentation, and follow‑up activities.
• Experience with change control and validation processes within a regulated environment.
• Knowledge of medical device regulatory requirements and their application to labeling and promotional materials.
• Previous experience supporting quality and regulatory audit activities, particularly related to labeling and documentation.
• Practical knowledge and demonstrated competence in a professional discipline, typically obtained through advanced education and experience.
• University degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.
• Ability to work independently with general supervision on moderately complex projects.
• Strong written and verbal communication skills for coordinating with internal stakeholders and documenting labeling activities.

Additional Skills & Qualifications

• Experience working within QMS Agile or comparable quality management systems.
• Familiarity with artwork and labeling development processes, including coordination with cross‑functional teams.
• Ability to monitor and interpret changes in global labeling regulations and integrate them into existing processes.
• Experience in a specialist or individual contributor role within a regulated industry, preferably medical devices.
• Ability to mentor or guide entry‑level professionals and support staff in labeling and quality‑related tasks.
• Demonstrated ability to make process improvements and recommend enhancements to systems and tools.
• Comfort working on cross‑functional assignments and contributing to project milestones.
• Advanced education in a relevant field is beneficial.

Job Type & Location

This is a Contract position based out of Minneapolis, MN.

Pay And Benefits

The pay range for this position is $30.00 - $39.00/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 hybrid position in Minneapolis,MN. Application Deadline This position is anticipated to close on Oct 8, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News‑Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 [e-mail] 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.