Job Title: Labeling SpecialistJob Description This role is responsible for the development, validation, and implementation of label designs for finished medical devices. The Labeling Specialist is an integral member of product development teams, utilizing their expertise to develop label designs that align with device risk management files and relevant regulatory requirements. They identify label printing process controls to ensure printed content is accurate and manage the transition into commercial manufacturing. This role also encompasses sustaining activities related to labeling, including changes and impact assessments, global regulatory compliance, addressing nonconformances and complaints, and process optimization. Responsibilities + Coordinate and execute label verification activities as necessary. + Review, assess, and approve design and process changes to existing package and label designs or processes. + Lead and coordinate labeling activities for new product launches, market expansions, and regulatory updates across departments. + Serve as the organizational subject matter expert for labeling requirements, including audits. + Draft and own labeling guidelines, templates, and processes within the Quality System. + Develop and validate label print artwork files and printing processes as necessary. + Create and maintain up-to-date product Design History Files (DHF). + Interface between manufacturing/PLM and supply chain/ERP to ensure batch-specific information is accurate across systems. Essential Skills + 3+ years of experience in a Labeling Specialist role. + Experience in Medical Device (ISO13485 & 21CFR820) standards. + Proficient in label design and management software such as BarTender and GSI Data Hub. + Experience using barcoding systems like GS1 and HIBC-128. + Strong understanding of global regulatory requirements for labeling. + Understanding of ISO and application of risk management to product development and processes. + Experience with IEC -1 testing/compliance, primarily labeling requirements. + Demonstrated use of quality tools and methodologies, such as nonconformance, CAPAs, and root cause analysis. + Experience with Product Lifecycle Management (PLM) software like Windchill, Agile, Propel. + Experience with Enterprise Resource Planning (ERP) software like Epicor and Net Suite. + Intermediate to advanced proficiency with MS Office Suite (Word, Excel, PowerPoint, Project, Outlook). Additional Skills & Qualifications + Degree in engineering, supply chain/logistics, business, or equivalent. + High attention to detail, organization, and accuracy. + Instinctual capability for creative thinking and proposing novel solutions. + Strong ability to communicate effectively both in writing and verbally within and across disciplines and organizational structures. + Familiarity with harmonized and recognized test standards for labeling. Work Environment The position is based in a brand-new facility in the Arber Lakes area with significant room for growth. The company values collaboration and brings unmatched core competence in medical device product design and development through manufacturing. The work environment is designed to leverage assets to accelerate the commercial side of business collaborations. Pay and Benefits The pay range for this position is $95000.00 - $125000.00/yr. Health & Wellness:- Employer-subsidized health insurance.- Employer-paid dental insurance.- Employer HSA contribution.- Gym membership subsidy.Financial Security:- 401k plan with company match.- Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance.Time Off & Flexibility:- 9 paid holidays (including your birthday!).-PTO and Personal days. Workplace Type This is a fully onsite position in Maple Grove,MN. Application Deadline This position is anticipated to close on Aug 25, 2025. 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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.