Associate Specialist Regulatory Labeling

Medline IndustriesNorthbrook, IL
81d$59,280 - $85,800Hybrid

About The Position

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

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.

Nice To Haves

  • 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.

Responsibilities

  • 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).

Benefits

  • Health insurance
  • Life and disability insurance
  • 401(k) contributions
  • Paid time off

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What This Job Offers

Job Type

Full-time

Industry

Miscellaneous Manufacturing

Education Level

Bachelor's degree

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