Medline Industries, LP · 8 hours ago
Regulatory Labeling Specialist, Clinical
Northfield, IL
Full-time
Onsite
Entry, Mid Level
$74K/yr - $107K/yr
2+ years expMedline Industries, LP is a global organization focused on enhancing patient safety through effective medical device labeling. The Regulatory Labeling Specialist will be responsible for ensuring compliance with state and federal regulations, conducting audits, and providing training on regulatory requirements.
Consumer GoodsHealth CareHospitalityManufacturingMedical
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)
Qualification
Required
Bachelor's Degree in Science or 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
Preferred
Apply clinical judgment and understanding of patient care workflows to ensure labeling and promotional materials accurately reflect safe and effective device use
Leverage firsthand experience with patient safety and clinical risk to assess labeling claims, precautions, and warnings for clinical relevance and clarity
Patient-centered thinking; clinical insight & risk communication; real-world understanding of how devices are used; end-user perspective
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
Contribute to cross-functional reviews (Regulatory Affairs, Legal, Clinical/Medical Affairs, Marketing, etc.) by providing insight into how messaging aligns with clinical practice and patient needs
Benefits
Health insurance
Life and disability
401(k) contributions
Paid time off
Company
Medline Industries, LP
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
10001+ employees
H1B Sponsorship
Medline Industries, LP has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (242)
2024 (144)
2023 (142)
2022 (143)
2021 (137)
2020 (113)
Funding
Current Stage
Public CompanyTotal Funding
$0.5MKey Investors
North Carolina Department of Commerce
2025-12-17IPO
2021-06-05Private Equity
2019-09-12Grant· $0.5M
Leadership Team
Steve Miller
Chief Operating Officer
Amanda Laabs
Chief Product Officer
Recent News
2025-12-26
TheStreet.com
2025-12-20
2025-12-19
Company data provided by crunchbase