Regulatory Labeling Specialist – FDA Compliance & QA

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

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Employee assistance program

Job summary

Medline Industries, LP in Illinois is seeking a Regulatory Affairs professional responsible for aligning product labeling content with FDA and federal regulations. Under general supervision, you will review and submit packaging submissions and ensure compliance.

You will work with cross-functional teams, train staff, and participate in process improvements and audits. The role offers a competitive salary range and comprehensive benefits.

Qualifications

• Bachelor’s degree in science or related field required.
• 2+ years of experience in Quality or Regulatory Affairs for a regulated industry.
• Knowledge of FDA product codes, product class structure, GMP, and QMS.
• Excellent communication, relationship-building, and project management skills.
• Experience in product labeling regulatory activities preferred.

Responsibilities

• Review, verify and complete packaging submissions to authorize label content.
• Evaluate supporting documentation for relevant regulatory authorities.
• Research regulatory changes for devices and OTC drugs with stakeholders.
• Inform divisions on regulatory requirements using documentation and risk assessment.
• Identify opportunities to improve processes and reduce waste.
• Participate in cross-department process improvement initiatives.
• Conduct internal audits and maintain department databases.
• Train and mentor staff on regulatory labeling requirements and procedures.

Skills

FDA product codes

Quality Management Systems

GMP

Communication

Project management

Critical thinking

Problem solving

Education

Bachelor’s Degree in Science or related field

Job description

Medline Industries, LP in Illinois is seeking a Regulatory Affairs professional responsible for aligning product labeling content with FDA and federal regulations. Under general supervision, you will review and submit packaging submissions and ensure compliance.

You will work with cross-functional teams, train staff, and participate in process improvements and audits. The role offers a competitive salary range and comprehensive benefits.