Manager Regulatory Compliance, Risk Management

Manager Regulatory Compliance, Risk Management – Medline Industries, LP

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.

• 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 Product Divisions, Finance, R&D, and Quality to ensure 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

• Education:
  
  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 to identify issues, trends, or exceptions to drive improvement and find solutions
• Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines
• Advanced level skill in Microsoft Excel (e.g., using AVERAGE function, merging and centering cells, creating pivot tables)
• Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally)

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

The Anticipated Salary Range For This Position: $ - $ Annual.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, and other benefits for employees working 30 or more hours per week on average. For a comprehensive list please refer to Medline’s benefits page.

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.