Associate Regulatory Labeling Specialist - Northfield, United States - Medline Industries Inc
Description
Primary Location US-IL-Northfield
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).
Education
- Bachelor's Degree in Science or related field.
Work Experience
- At least 2 years of experience in Quality or Regulatory Affairs for a regulated industry.
Knowledge / Skills / Abilities
- 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.
PREFERRED JOB REQUIREMENTS
- At least 2 years of experience in a product labelingrelated role for a regulated industry.
- Experience evaluating regulatory risk.
- Experience in project management using critical thinking and problem solving abilities to deliver results.
- Experience in evaluation of information to determine compliance with standards, laws, and regulations.
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