Product Support Regulatory Affairs Specialist

Medline; Chicago (IL); On-site; USD 32,000 - 46,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline is seeking a Regulatory Analyst to ensure adherence to regulatory requirements for new and existing items, with a focus on data accuracy across Medline databases. The role involves evaluating classifications, device class numbers, storage, sterility, and drug pedigree provisions.

You will support monthly audits, respond to inquiries, and propose process improvements with cross-functional teams. Prior experience in pharma distribution documentation and data management is preferred.

Qualifications

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

Responsibilities

• Analyze manufacturer websites and medical databases to research regulatory requirements for newly created items to ensure Medline databases are accurate and complete.
• Assist with monthly and quarterly team audit projects to prevent federal audits and/or financial losses.
• Respond to inquiries surrounding regulatory requirements via established mailboxes, assessing several variables while communicating what can be communicated.
• Review portfolio analytics to submit process improvement recommendations to management for business impact.
• Submit assigned files and/or projects to management within provided timelines.
• Establish and maintain close working relationships with Divisional personnel, Corporate Quality, Sales Representatives, and Warehouse Operations.

Skills

Excel

Outlook

Time management

Cross-team collaboration

SAP

Zendesk

Data management

Education

Bachelor's degree

Tools

SAP

Zendesk

Job description

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.

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).
• Knowledge / Skills / Abilities: 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.
• Relevant Work Experience: 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 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 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

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.

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.

If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you.

Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. To learn more about how Medline makes healthcare run better, visit www.medline.com.