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MI
Medline Industries, LP
Associate Regulatory Labeling Specialist
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Based on Illinois data
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What they do
A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
$93,174 / year median in Illinois
+2% projected growth
Job Description
Job Summary Medline Industries has an immediate opening for an Associate Regulatory Labeling Specialist. This role will be based out of our Northfield, IL corporate headquarters and will work a hybrid model. Job Description
JOB SUMMARY
Under direct supervision, responsible for support of labeling projects through review and alignment of product artwork content with state and federal regulations.MAJOR 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 trainingof divisional personnel on regulatory product structure, regulatory labeling requirements, and Medline's labeling procedure(s).
MINIMUM JOB REQUIREMENTS
Education- Bachelor's Degree or High School Diploma with at least 4 years relevant job experience. Work 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.
Knowledge / Skills
/ Abilities- 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
Education- Bachelor's Degree in a science related field. Work Experience
- 1 year of experience in a Quality or Regulatory role for a regulated industry.
Knowledge / Skills
/ Abilities- 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. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $62,000.00
- $93,000.