Product Support Regulatory Affairs Spec

Regulatory Compliance Analyst

To ensure adherence and overall accuracy of regulatory requirements to newly created and existing items within Medline. Routinely involves judgement calls, exercising discretion, and problem-solving skills that stem from internally identified discrepancies. Requires a thorough understanding of several areas of the business that consistently leads to making decisions that have material financial implications.

Responsibilities

• Analyze manufacturer websites and other medical databases to research regulatory requirements for newly created items to ensure Medline databases are accurate and complete.
• Requirements include but are not limited to item classifications, device class number, storage conditions, sterility, storage handling, and / or drug pedigree provisions.
• Assist with monthly and quarterly team audit projects, necessitating high levels of accuracy to prevent federal audits and / or financial losses.
• Respond to inquiries surrounding regulatory requirements and / or discrepancies via established mailboxes, requiring the assessment of several variables while administering discretion on what can and cannot be communicated.
• Review portfolio analytics to submit process improvement recommendations to management for business impact.
• Submit assigned files and / or projects to management and / or internal team(s) within provided timelines.
• Establish and maintain a close working relationship with the following groups : Divisional personnel, Corporate Quality, Sales Representatives, and Warehouse Operations.

Requirements

Preferred Requirements

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 : $23.25 - $32.50 Hourly. The actual salary will vary based on applicant's location, education, experience, skills, and abilities. 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.

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.