Sr Manager Regulatory Compliance, Risk Management and Clinical

Medline Industries, LP•Mundelein, IL

1d•$154,000 - $231,000

About The Position

This role is responsible for leading the clinical product surveillance and risk management teams. Management of the clinical product surveillance team will ensure that Medline’s adverse event reporting strategy is compliant and aligned with FDA’s requirements. Management of the risk management team will include ensuring that Medline’s processes (such as design and post market surveillance) have adequate risk management requirements built in that align to ISO 14971.

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 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.

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