Senior Post-Market Safety & MDR Lead

Medline Industries, Inc. in; Mundelein (IL); On-site; USD 92,000 - 138,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a seasoned professional to lead post-market surveillance and risk management for medical device and pharmaceutical products. You will evaluate complaints, prepare regulatory reports, and provide clinical support to QA, product divisions, and sales teams.

You will mentor the Clinical Product Surveillance team, oversee risk analysis, and help develop reporting procedures to ensure compliance with FDA and international health authorities.

Qualifications

• Bachelor's degree in medical sciences or healthcare field plus 4+ years clinical risk management experience.
• Healthcare provider certificate/licensure.
• 6+ years clinical, medical device risk management experience.
• Experience analyzing data to identify issues and drive improvements.
• Ability to communicate technical information to non-technical audiences.
• Experience with cross-functional teams and project coordination.
• Strong time management and ability to handle multiple projects.
• Proficiency with Microsoft Office.

Responsibilities

• Identify complaints affecting patient safety and evaluate them.
• Prepare and submit MDRs and adverse event reports to the FDA.
• Coordinate international reports with local health authorities.
• Collaborate with QA and product division as a clinical resource.
• Lead patient safety and risk analysis activities.
• Develop procedures for MDR and adverse event reporting.
• Conduct trainings on post-market surveillance and SOP requirements.
• Mentor the Clinical Product Surveillance team.

Skills

Data analysis

Technical communication

Cross-functional teamwork

Time management

Self-motivation

Microsoft Office

Education

Bachelor's degree in medical sciences or healthcare

Healthcare provider certificate/licensure

Bachelor’s Degree in Nursing

Tools

Microsoft Office

Job description

Medline Industries, LP seeks a seasoned professional to lead post-market surveillance and risk management for medical device and pharmaceutical products. You will evaluate complaints, prepare regulatory reports, and provide clinical support to QA, product divisions, and sales teams.

You will mentor the Clinical Product Surveillance team, oversee risk analysis, and help develop reporting procedures to ensure compliance with FDA and international health authorities.