Clinical Product Safety & Risk Specialist

Medline Industries, LP; Mundelein (IL); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Clinical Product Surveillance Specialist to independently investigate post-market complaints and provide clinical resource support. You will act as a patient safety advocate, collaborate across cross-functional teams, and ensure compliance with post-market regulations.

The role emphasizes RN licensure, clinical risk assessment, and coordination with regulatory bodies, with a detailed focus on safety, quality, and product improvement across domestic and

Qualifications

• BSN and active RN license in good standing.
• Minimum 5 years patient care experience or 4 years with BSN plus 2 years in a similar role.
• Familiarity with post-market surveillance and adverse event reporting processes.
• Knowledge of quality improvement, patient safety and clinical workflows.

Responsibilities

• Identify and investigate post-market complaints with potential safety issues.
• Process and submit adverse event reports (MDRs, ICSS) to FDA timely.
• Coordinate medical device adverse event reporting with health authorities.
• Collaborate with cross-functional teams as clinical resource for customers.
• Ensure communications to internal and external customers are clear and accurate.
• Review customer responses for technical and clinical accuracy.
• Provide clinical insight during post-market, risk management, and design changes.
• Analyze safety and risk data to identify trends and issues requiring action.
• Assist with Health Hazard Evaluations, recalls, or field actions as needed.
• Support CAPAs and SOP maintenance related to clinical risk evaluation.

Skills

Quality improvement

Patient safety

Clinical workflows

Data analysis

Microsoft Office

Education

Bachelor's Degree in Nursing (BSN)

Tools

Microsoft Excel

MS Office

Job description

Medline Industries, LP is seeking a Clinical Product Surveillance Specialist to independently investigate post-market complaints and provide clinical resource support. You will act as a patient safety advocate, collaborate across cross-functional teams, and ensure compliance with post-market regulations.

The role emphasizes RN licensure, clinical risk assessment, and coordination with regulatory bodies, with a detailed focus on safety, quality, and product improvement across domestic and