Spec Regulatory Labeling

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

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).

MINIMUM JOB REQUIREMENTS:

• Education: Bachelor’s Degree in Science or related field.
• Certification / Licensure: None
• 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.
• Knowledge / Skills / Abilities: Excellent communication and relationship building skills, project management, critical thinking and problem solving abilities to deliver results and meet deadlines.

PREFERRED JOB REQUIREMENTS:

• Education: None
• Certification / Licensure: None
• Work Experience: At least 2 years of experience in a product labeling-related role for a regulated industry.
• Work Experience: Experience evaluating regulatory risk.
• Work Experience: Experience in project management using critical thinking and problem solving abilities to deliver results.
• Work Experience: Experience in evaluation of information to determine compliance with standards, laws, and regulations.
• Knowledge / Skills / Abilities: None

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: $79,000.00 - $119,000.00 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 roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

For a more comprehensive list of our benefits please click here.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time.

If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you.

Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.

Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes.

Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories.

To learn more about how Medline makes healthcare run better, visit www.medline.com.