Senior Clinical Product Surveillance Lead

Medline; Chicago (IL); On-site; USD 92,000 - 138,000; Full time

Job summary

Medline is seeking a qualified Clinical Product Surveillance professional to oversee post-market safety assessments and lead clinical investigations for product incidents. You will mentor the team, conduct risk analyses, and ensure compliance with post-market regulations while supporting QA and product divisions.

The role involves preparing MDRs, coordinating international reporting, and providing clinical guidance to customers and sales teams.

Qualifications

• Bachelor's degree in medical science, health sciences or healthcare field plus 4+ years in clinical, medical device risk management or pharma risk management, or healthcare licensure.
• At least 6 years of clinical, medical device risk management, or pharmaceutical risk management experience.
• Experience communicating technical information to non-technical audiences.
• Experience with cross-functional teams and facilitating solutions to complex problems.
• Experience using time management to juggle multiple projects.

Responsibilities

• Identify and evaluate complaints affecting patient safety.
• Prepare and submit MDRs and adverse event reports to the FDA.
• Coordinate international report filing with local health authorities.
• Ensure reportable complaints are processed and submitted.
• Collaborate with QA and product division as a clinical resource.
• Lead risk analyses and design modifications for products.

Skills

Data analysis

Communication to non-technical

Cross-functional teamwork

Time management

Self-motivation / independent work

Education

Bachelor’s degree in medical sciences / health sciences / healthcare

Bachelor’s Degree in Nursing

Tools

Microsoft Office

Job description

Medline is seeking a qualified Clinical Product Surveillance professional to oversee post-market safety assessments and lead clinical investigations for product incidents. You will mentor the team, conduct risk analyses, and ensure compliance with post-market regulations while supporting QA and product divisions.

The role involves preparing MDRs, coordinating international reporting, and providing clinical guidance to customers and sales teams.