Medline · 3 days ago
Sr Manager Regulatory Compliance, Risk Management and Clinical
Mundelein, IL
Full-time
Onsite
Senior Level
$154K/yr - $231K/yr
7+ years expMedline is a leading organization in the medical device industry, seeking a Senior Manager for Regulatory Compliance, Risk Management, and Clinical. This role involves leading clinical product surveillance and risk management teams to ensure compliance with FDA regulations and ISO standards while managing risks associated with medical devices, OTC drugs, and cosmetics.
Consumer GoodsHealth CareHospitalityManufacturingMedical
Responsibilities
Lead the corporate risk management team and clinical product surveillance teams. Develop and coach employees across all teams
Ensure that Medline is properly controlling risks on a global level for medical devices, OTC drugs, and cosmetics
Ensure proper implementation if ISO 14971 requirements within Medline’s Quality Management System
Participate in and manage team members who participate in Health Hazard Evaluation (HHE) meetings and assist in recall and field action decisions
Maintain compliance with 21 CFR Part 803 (Medical Device Reporting) and ensure Medline’s MDR reporting strategy aligns with FDA requirements
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
Qualification
Required
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 or clinical product surveillance
Deep understanding of FDA regulations including 21 CFR Part 7, Part 806, Part 803, ISO 14971, and ISO 13485
Proven experience managing complex recall events and regulatory submissions
Strong leadership, communication, and project management skills
Experience with FDA audits and internal quality audits
Benefits
Health insurance
Life and disability
401(k) contributions
Paid time off
Company
Medline
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
10001+ employees
H1B Sponsorship
Medline 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 (344)
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
Packaging-Gateway.com
2026-01-16
2026-01-13
Company data provided by crunchbase