Labeling 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. 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. 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. Job Type & Location This is a Permanent 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 21, 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 View email address on click.appcast.io 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. #J-18808-Ljbffr Actalent