Senior Post-Market Clinical Surveillance Lead

Medline Industries, LP; 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 is seeking a Clinical Product Surveillance professional to lead post-market investigations, evaluate complaints, and coordinate MDR submissions with FDA and international authorities. You will mentor the Clinical Product Surveillance team and provide clinical expertise to QA and product divisions.

The role requires a Bachelor's degree in medical sciences or healthcare field and at least 6 years of clinical or risk management experience, with strong data analysis and

Qualifications

• Bachelor's degree in medical science or related field and at least 4 years of clinical, medical device risk management, or pharmaceutical risk management experience OR Healthcare provider certificate/licensure.
• Experience documenting and reporting safety data for regulatory programs.
• Ability to communicate technical information to non-technical audiences.

Responsibilities

• Identify and evaluate complaints affecting patient safety.
• Prepare and submit MDRs and adverse event reports to FDA.
• Coordinate international report filing with health authorities.
• Lead risk analyses and develop product risk controls.
• Provide clinical support to QA, sales, and product teams.

Skills

Data analysis

Technical communication

Cross-functional teamwork

Project management

Time management

Microsoft Office

Education

Bachelor's degree in medical science/health sciences or healthcare related field

Healthcare provider certificate/licensure

Tools

Microsoft Office

Job description

Medline Industries, LP is seeking a Clinical Product Surveillance professional to lead post-market investigations, evaluate complaints, and coordinate MDR submissions with FDA and international authorities. You will mentor the Clinical Product Surveillance team and provide clinical expertise to QA and product divisions.

The role requires a Bachelor's degree in medical sciences or healthcare field and at least 6 years of clinical or risk management experience, with strong data analysis and