Regulatory Labeling Specialist, Clinical

Medline • Northfield, MN

20d

About The Position

Ideal for scientists, engineers, healthcare professionals, etc. seeking to expand their impact on patient safety and outcomes through the development and oversight of clear, compliant, and effective medical device labeling and advertising/promotional communications. Under general supervision, responsible for aligning product labeling content with state and federal regulations.

Requirements

• 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.

Nice To Haves

• 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.

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).

Benefits

• Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
• 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 as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees