Sr Manager Regulatory Compliance, Risk Management and Clinical

Job Summary

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.

Job Description

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.

Management Responsibilities:

• 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

Qualifications:

• 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.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$154,000.00 - $231,000.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

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.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here .

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.