Product Support Regulatory Affairs Specialist

Medline Industries, LP•Northfield, IL

1d•$23 - $34

About The Position

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.

Requirements

Bachelor’s degree or equivalent professional experience in a related field
At least one year of customer service and product research experience with an ability to manage workloads that allow for product-specific analytics to occur for departmental process improvement(s).
Intermediate skill level in Microsoft Excel (i.e. VLOOKUP, Pivot Tables, IF Statements, SUM function and sort/filter).
Intermediate skill level in Microsoft Outlook (i.e. creating folders, categories, utilizing calendar, and coordinating meetings).

Nice To Haves

Bachelor's degree.
Advanced time management skills to ensure daily work, discrepancies and/or projects are accomplished within given SLA’s.
Experience building and maintaining relationships within and between teams/vendors.
Advanced skill level in Microsoft Excel (i.e. macros and advanced formulas).
Exposure/experience with SAP and/or Zendesk
At least 1 year of experience with pharmaceutical drug distribution documentation and tracking.
At least 1 year of experience with data management.

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.