• Labeling Specialist

    Actalent (Irvine, CA)


    Labeling Specialist job opportunity with large Medical Device company!

    Description

    + Accountable for the regulatory labeling deliverables for various project types i.e. submission new product development sustaining launches manufacturing transfer etc.

    + Manage and support assessment and template creation for new and changing requirements.

    + Prepare technical product documentation including plans reports and engineering change orders etc.

    + Maintain artwork content for all labeling types including Instructions for Use documents product labels Patient labeling electronic labeling label stocks and carton in compliance with applicable regulations standards company policies processes as well as internal labeling requirements.

    + Estimates labeling projects level of effort resource requirements and works with stakeholders to understand the scope of effort and tasks necessary to complete the project.

    + Collaborate with multi-functional team RampD engineering marketing manufacturing operations regulatory legal quality clinical medical safety to facilitate completion of labeling artwork projects

    + Tracks labeling project schedules identify risks/issues determine resolution and communicates project status or escalations by participating in departmental and project team meetings.

    + Keeps abreast of regulatory procedures and changes.

    + May direct interaction with regulatory agencies on defined matters.

    + Manage labeling UDI and barcode grading processes and systems as related to product labeling

    + Other duties as assigned or required

    Requirements:

    + EU Labeling Requirements

    + Global labeling requirements 21 CFR 801 EU MDR Regulation ISO15223 ISO20417

    + Project Management and Change Management skills

    + Education Required: MS in Science engineering or regulatory.

    + Years’ Experience Required: 5-9 years

     

    Job Type & Location

     

    This is a Contract to Hire position based out of Irvine, CA.

    Pay and Benefits

    The pay range for this position is $45.00 - $45.00/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)

     

    Workplace Type

     

    This is a fully onsite position in Irvine,CA.

     

    Application Deadline

     

    This position is anticipated to close on Nov 26, 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 [email protected] (%[email protected]) for other accommodation options.