Regulatory Labeling Specialist — FDA Compliance & QA

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

Job summary

Medline Industries, LP in Chicago seeks a regulatory labeling specialist to align product labeling content with state and federal regulations under general supervision. You will review packaging submissions, verify supporting documents, inform divisions of requirements, and contribute to continuous improvement through kaizen and cross‑department initiatives.

The role requires a Bachelor's degree, at least two years in quality or regulatory affairs, knowledge of FDA product codes, QMS and GMP,

Qualifications

• Bachelor's Degree in Science or related field.
• At least 2 years of experience in Quality or Regulatory Affairs for a regulated industry.
• Knowledge of FDA product codes, Quality Management Systems and GMP.
• Strong communication, relationship-building, and project management skills with problem-solving ability.

Responsibilities

• Review, verify and complete packaging submissions to authorize label related content based on regulations and product claims.
• 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.
• 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).

Skills

FDA product codes

Quality Management Systems

Good Manufacturing Practices

Communication skills

Project management

Critical thinking

Education

Bachelor's degree

Job description

Medline Industries, LP in Chicago seeks a regulatory labeling specialist to align product labeling content with state and federal regulations under general supervision. You will review packaging submissions, verify supporting documents, inform divisions of requirements, and contribute to continuous improvement through kaizen and cross‑department initiatives.

The role requires a Bachelor's degree, at least two years in quality or regulatory affairs, knowledge of FDA product codes, QMS and GMP,