Product Support Regulatory Affairs Specialist
Job Summary
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.Job Description
MAJOR 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.
MINIMUM JOB REQUIREMENTS:
Education:
- Bachelor’s degree or equivalent professional experience in a related field
Work Experience:
- 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).
Knowledge / Skills / Abilities:
- 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).
PREFERED QUALIFICATIONS:
Education:
- Bachelor's degree.
Additional:
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
Relevant Work Experience:
- At least 1 year of experience with pharmaceutical drug distribution documentation and tracking.
- At least 1 year of experience with data management.
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 - $33.75 HourlyThe 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 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 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.