Associate Specialist Regulatory Labeling

Medline Industries • Northbrook, IL

81d • $59,280 - $85,800 • Hybrid

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

What This Job Offers

• Job Type: Full-time
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree