Manager Regulatory Compliance, Risk Management

Medline Industries, LP • Mundelein, IL

14d • $115,440 - $173,160

About The Position

This role will be directly managing Medline’s Risk Management Team within the Regulatory Compliance department. Responsible for implementing and maintaining risk management processes throughout Medline’s Quality Management System.

Requirements

• Bachelor’s Degree in Engineering, Science, or related field.
• At least 4 years of experience working with QSR/GMP/ISO requirements or other regulated industries.
• Experience analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
• Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.
• Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).
• Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally).

Nice To Haves

• Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries.
• Experience with Tableau or other data analysis tools.

Responsibilities

• Own and continually improve Medline’s risk management system (policy, SOPs, forms, templates) to ensure consistent, lifecycle‑wide application aligned to ISO 14971 and internal Design Control practices
• Evaluate the risks and act as an approver for the following processes: Change Controls, Failure Mode Effect Analysis (FMEA), Medical Device Reporting (MDR), Recalls, Health Hazard Evaluations (HHEs), and other major quality events.
• Represent Medline as risk management SME in BSI/MDSAP/FDA assessments; lead preparation, conduct real‑time issue resolution, and drive sustainable corrective actions.
• Act as a liaison with cross-functional teams such as Divisional risk management information is gathered, evaluated, and communicated to make informed decisions on product and process improvement. Product Divisions, and/or Finance to ensure R&D, and/or Quality, International Quality,
• Develop new approaches and strategies to solve problems related to global post-market surveillance and regulatory compliance.
• Identify and manage the execution of continuous improvement projects.
• Assist divisions in risk management activities from a global market and regulatory compliance standpoint.
• Monitor changes in the regulatory environment, with a focus on ISO 14971, and implement required changes to procedures and processes to maintain regulatory compliance. Escalate to upper management as needed.
• Typically oversee professional employees/teams;
• Day-to-day operations of a group of employees;
• Oversee major projects/programs/outcomes;
• May have budgetary responsibility and usually contributes to budgetary impact;
• Interpret and execute policies for departments/projects;
• Recommend and implement new policies or modifications to existing policies;
• Provide general guidelines and parameters for staff functioning;
• Hire staff, recommend pay increases, perform performance reviews, train and develop staff ,estimate personnel needs, assign work, meet completion dates, interpret and ensure consistent application of organizational policies.

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.

What This Job Offers

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