Spec Regulatory Labeling

Medline; Chicago (IL); Sur place; USD 79 000 - 119 000; Plein temps

Avantages offerts par ce poste

Health insurance

Life and disability

401(k) contributions

Paid time off

Résumé du poste

Medline Industries, LP seeks a Regulatory Labeling Specialist to align packaging content with state and federal regulations. Under general supervision, you will review submissions, verify content, and ensure compliance for labels and product claims.

You will research regulatory changes, train staff, and participate in cross-department improvement initiatives while maintaining internal databases and audits. A Bachelor’s in science and 2+ years of regulatory or quality experience are required.

Qualifications

• Bachelor's degree in Science or related field.
• 2+ years in Quality or Regulatory Affairs for a regulated industry.
• Knowledge of FDA product codes, QMS and GMP.
• Strong communication and project management skills.
• Ability to research regulations and advise stakeholders.

Responsabilités

• 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.
• Identify and execute opportunities for improvement through the simple kaizen process.
• Participate in 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 labeling requirements.

Connaissances

Regulatory knowledge

Communication

Project management

Critical thinking

Formation

Bachelor's Degree in Science

Description du poste

Job Summary

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

Job Description

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.
• 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.
• 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.
• 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.

Salary

$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.

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.

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.