Regulatory Labeling Specialist

Job Summary

Under general supervision, responsible for aligning product labeling content with state and federal regulations.

Job Description

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).

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 / 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 Qualifications:

• 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.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$73,840.00 - $107,120.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

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.