Spec Regulatory Labeling

Medline • Chicago, IL

1d • $79,000 - $119,000

About The Position

Under general supervision, the Spec Regulatory Labeling aligns product labeling content with state and federal regulations. The role reviews and completes packaging submissions, evaluates supporting documentation, researches regulatory changes and requirements for devices and OTC drugs, and advises divisions on labeling requirements and content. It also supports process improvement, conducts internal audits, maintains department records, and trains and mentors employees and business partners on regulatory product structure and labeling procedures.

Requirements

• Bachelor’s degree in Science or a 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.

Nice To Haves

• At least 2 years of experience in a product labeling-related role for a regulated industry.
• Experience evaluating regulatory risk.
• Experience in project management using critical thinking and problem-solving abilities to deliver results.
• Experience evaluating information to determine compliance with standards, laws, and regulations.

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 regulatory changes and review requirements for devices and OTC drugs with stakeholders.
• Inform divisions of requirements and content using documentation, market knowledge, and risk assessment.
• Influence changes 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 of files, processes, databases, and related materials.
• 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 procedures.

Benefits

• Continuing education and training.
• Competitive total rewards package.
• Bonus and/or incentive eligibility.
• Health insurance.
• Life insurance.
• Disability insurance.
• 401(k) contributions.
• Paid time off.
• Access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp for employees working less than 30 hours per week.

What This Job Offers

• Job Type: Full-time