Spec Regulatory Labeling
Medline Industries, LP
Summary
Under general supervision, responsible for aligning product labeling content with state and federal regulations.
Job description
Job Summary
Under general supervision, responsible for aligning product labeling content with state and federal regulations.
Major Responsibilities
- Review, verify and complete packaging submissions to authorize label related content based on regulations and product claims. Evaluate supporting documentation for relevant regulatory authorities.
- Research changes with regulations and review requirements for devices and OTC drugs with stakeholders.
- Inform divisions on requirements and content using documentation, market knowledge, and assessment of risk. Influence change to improve processes and eliminate waste.
- Identify and execute opportunities for improvement through the simple kaizen process.
- Participate in the CTIQ team/Cross departmental team process improvement program.
- Conduct internal audits (files, processes, databases, etc.) and maintain department databases, logs and files.
- Train and mentor new employees, divisional QA's and product managers on regulatory product structure, regulatory labeling requirements, and Medline labeling procedure(s).
Requirements
- Bachelor's Degree in Science or related field
- At least 2 years of experience in Quality or Regulatory Affairs for a regulated industry
- 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
Benefits
- Health Insurance
- Life & Disability Insurance
- 401(k) Contributions
- Paid Time Off
- Employee Assistance Program
- Employee Resource Groups
- Employee Service Corp
- Continuing Education & Training
Company overview
Medline Industries, LP is the largest privately held manufacturer and distributor of medical-surgical products and supply chain solutions in the United States. Founded in 1966 and headquartered in Northfield, Illinois, the company serves all points of care including hospitals, extended care facilities, surgery centers, physician offices, home care agencies, and retailers. With over 550,000 medical products and clinical solutions, Medline operates in more than 125 countries and territories worldwide. The company employs approximately 35,000-43,000 people globally and generates annual revenues exceeding $21 billion. Medline's comprehensive portfolio includes medical devices, surgical supplies, wound care products, protective apparel, durable medical equipment, and sterilization solutions. The company combines manufacturing expertise with extensive distribution capabilities through its network of over 50 distribution centers across North America, providing integrated supply chain solutions that help healthcare organizations improve clinical, financial, and operational outcomes.