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Associate Specialist Regulatory Labeling

Associate Specialist Regulatory Labeling

Medline IndustriesChicago, IL, US
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Labeling Project Manager

Under direct supervision, responsible for support of labeling projects through review and alignment of product artwork content with state and federal regulations.

Major responsibilities include :

  • Review, verify and complete packaging submission to graphic design team authorizing label related content based on product's regulatory structure and documented product claims support. Evaluate supporting documentation for relevance to desired product claims.
  • Review, approve and document product labeling (packaging / collateral) for compliance to product's regulatory structure and QMS requirements. Interpret and analyze state and federal regulations to ensure product labels are accurate and in compliance.
  • Periodic audit of historic files, processes, databases, etc. and maintenance of company / department databases, logs, and files.
  • Using a customer service approach, timely and effective communication and support of internal customers (product divisions).
  • Support training of divisional personnel on regulatory product structure, regulatory labeling requirements, and Medline's labeling procedure(s).

Minimum job requirements :

  • Bachelor's Degree or High School Diploma with at least 4 years relevant job experience.
  • Experience providing customer service to internal and external customers, including meeting quality standards for services and evaluation of customer satisfaction.
  • Experience in processing all relevant details, evaluating and prioritizing their importance, and drawing clear and concise conclusions.
  • Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).
  • Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
  • Preferred job requirements :

  • Bachelor's Degree in a science related field.
  • 1 year of experience in a Quality or Regulatory role for a regulated industry.
  • Basic knowledge and understanding of FDA product codes and product class structure, Quality Management Systems and Good Manufacturing Practices, or willingness to learn through training and independent research.
  • Excellent communication and relationship building skills. Project management, critical thinking and problem solving abilities to deliver results and meet deadlines.
  • Work experience in evaluating information to determine compliance with standards, laws, and regulations.
  • The anticipated salary range for this position :

    $59,280.00 - $85,800.00 Annual

    The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and / or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

    Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

    We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.

    Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

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    Regulatory Specialist • Chicago, IL, US

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