Medline Industries, LP · 9 hours ago
Manager Regulatory Compliance, Risk Management
Mundelein, IL
Full-time
Onsite
Mid Level
$115K/yr - $173K/yr
4+ years expMedline Industries, LP is a growing worldwide organization seeking a Manager for their Regulatory Compliance and Risk Management team. This role involves managing risk management processes, ensuring compliance with regulatory standards, and overseeing the development and execution of continuous improvement projects.
Consumer GoodsHealth CareHospitalityManufacturingMedical
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
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
Qualification
Required
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)
Preferred
Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries
Experience with Tableau or other data analysis tools
Benefits
Health insurance
Life and disability
401(k) contributions
Paid time off
Company
Medline Industries, LP
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
10001+ employees
H1B Sponsorship
Medline Industries, LP has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (242)
2024 (144)
2023 (142)
2022 (143)
2021 (137)
2020 (113)
Funding
Current Stage
Public CompanyTotal Funding
$0.5MKey Investors
North Carolina Department of Commerce
2025-12-17IPO
2021-06-05Private Equity
2019-09-12Grant· $0.5M
Leadership Team
Steve Miller
Chief Operating Officer
Amanda Laabs
Chief Product Officer
Recent News
2025-12-26
TheStreet.com
2025-12-20
2025-12-19
Company data provided by crunchbase