Regulatory Affairs Specialist - Labeling at Medline Industries, Inc. in Northfield, Illinois

Job Description:

Job Summary

Job Description

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 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 in evaluation of information to determine compliance with standards, laws, and regulations.

Benefits - Medline is committed to offering competitive benefits and a variety of choices to best meet the needs of you and your family. For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more. Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps. For a more comprehensive list of our benefits, please click here.

Every day, we’re focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what’s right to delivering business results, together, we’re better. Explore our Diversity, Equity and Inclusion page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.