Regulatory Labeling Specialist — Ensure Accurate Labels

Medline; Chicago (IL); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a Regulatory Labeling Specialist to align packaging content with state and federal regulations. Under general supervision, you will review submissions, verify content, and ensure compliance for labels and product claims.

You will research regulatory changes, train staff, and participate in cross-department improvement initiatives while maintaining internal databases and audits. A Bachelor’s in science and 2+ years of regulatory or quality experience are required.

Qualifications

• Bachelor's degree in Science or related field.
• 2+ years in Quality or Regulatory Affairs for a regulated industry.
• Knowledge of FDA product codes, QMS and GMP.
• Strong communication and project management skills.
• Ability to research regulations and advise stakeholders.

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.
• Identify and execute opportunities for improvement through the simple kaizen process.
• Participate in 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 labeling requirements.

Skills

Regulatory knowledge

Communication

Project management

Critical thinking

Education

Bachelor's Degree in Science

Job description

Medline Industries, LP seeks a Regulatory Labeling Specialist to align packaging content with state and federal regulations. Under general supervision, you will review submissions, verify content, and ensure compliance for labels and product claims.

You will research regulatory changes, train staff, and participate in cross-department improvement initiatives while maintaining internal databases and audits. A Bachelor’s in science and 2+ years of regulatory or quality experience are required.