Senior Post-Market Clinical Surveillance Lead

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

Job summary

Medline Industries, LP is seeking a Senior Clinical Product Surveillance professional to assess complaints, lead investigations, and determine post-market actions to ensure patient safety.

The role includes submitting MDRs, coordinating international reporting, mentoring the Clinical Product Surveillance team, and providing clinical guidance to QA, sales, and product divisions. Strong analytical and communication skills are essential.

Qualifications

• Bachelor's degree in medical science, health sciences or healthcare field.
• At least 4 years of clinical or risk-management experience.
• Healthcare provider certificate/licensure acceptable.
• Six years of clinical, medical device risk management or pharmaceutical risk management experience.

Responsibilities

• Identify and evaluate complaints affecting patient safety.
• Prepare and submit MDRs and adverse event reports to the FDA.
• Process MDRs and coordinate international reporting with health authorities.
• Collaborate with QA and product division; provide clinical resources.
• Review and classify potential reportable safety complaints.
• Develop procedures for MDR/Adverse Event Reporting across products.
• Lead risk analysis and design modification discussions; mentor team.
• Lead post-market surveillance trainings and internal SOP adherence.

Skills

Data analysis

Technical communication

Cross-functional teamwork

Time management

Self-motivation

Microsoft Office

Education

Bachelor's degree in medical science/healthcare field

Nursing license (preferred)

Job description

Medline Industries, LP is seeking a Senior Clinical Product Surveillance professional to assess complaints, lead investigations, and determine post-market actions to ensure patient safety.

The role includes submitting MDRs, coordinating international reporting, mentoring the Clinical Product Surveillance team, and providing clinical guidance to QA, sales, and product divisions. Strong analytical and communication skills are essential.