Sr. Manager Regulatory Compliance

Medline • Mundelein, IL

3d

About The Position

This role is responsible for leading the recall team, risk management team, and clinical product surveillance teams. Management of the recall team will include ensuring timely, compliant, and effective execution of recalls, corrections, and removals, while managing cross-functional teams and interfacing with regulatory authorities such as the FDA. Management of the risk management team will include ensuring that quality data is being adequately analyzed and that Medline is properly implementing risk mitigating strategies across the organization. Management of the clinical product surveillance team will ensure that Medline’s adverse event reporting strategy is compliant and aligned with FDA’s requirements.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field
• Minimum 7 years of experience in medical device regulatory compliance or quality assurance, with at least 3 years in recall management, risk management, or clinical product surveillance.
• Deep understanding of FDA regulations including 21 CFR Part 7, Part 806, Part 803, ISO 13485, and ISO 14971.
• Proven experience managing complex recall events and regulatory submissions.
• Strong leadership, communication, and project management skills.
• Experience with FDA audits and internal quality audits.

Nice To Haves

• At least 5 years of direct experience with recall management

Responsibilities

• Lead the corporate recall team, risk management team, and clinical product surveillance teams.
• Develop and coach employees across all teams.
• Lead the planning and execution of voluntary and mandatory recalls, product corrections, and removals in accordance with FDA regulations.
• Participate in and manage team members who participate in Health Hazard Evaluation (HHE) meetings and assist in recall and field action decisions, including determination of recall strategy.
• Ensure timely submission of FDA Form 806 and related documentation, as well as timely submissions of status reports and termination requests.
• Maintain compliance with 21 CFR Part 7 (Recall Policy) and 21 CFR Part 806 (Reports of Corrections and Removals).
• Maintain compliance with 21 CFR Part 803 (Medical Device Reporting) and ensure Medline’s MDR reporting strategy aligns with FDA requirements.
• Determine strategy for implementation of risk management activities across Medline’s QMS.
• Serve as the primary liaison with FDA as it relates to recall and adverse event communication.
• Monitor and interpret regulatory changes related to field actions, adverse event requirements, and risk management, and ensure internal procedures are updated accordingly.
• Ensure timelines for all projects and deadlines are being met by the team.
• Provide routine updates to Management on team performance and progress on projects.
• Facilitate internal meetings with cross-functional teams and ensure alignment across stakeholders, including Sales Leadership and Divisional Leadership.
• Typically manages through multiple Managers and/or Supervisors
• Oversee major projects/programs/outcomes
• Budget responsibility
• Interpret and execute policies for departments/projects; develop, recommend and implement new policies or modifications to existing policies
• Provide general guidelines and parameters for staff functioning
• Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring 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