Senior Clinical Product Safety & Surveillance Lead

Medline Industries Holdings LP; Mundelein (IL); In loco; USD 92.000 - 138.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

401(k) contributions

Paid time off

Life and disability

Descrizione del lavoro

Medline Industries, LP is seeking a Senior Clinical Safety professional to oversee post-market surveillance, assess incoming complaints, and lead clinical investigations for adverse events. You will prepare MDRs and coordinate international reporting, ensuring timely and accurate communications with health authorities.

With mentorship responsibilities, you will coach the Clinical Product Surveillance team, collaborate with QA and product divisions, and drive risk analyses and design

Competenze

• Experience analyzing and reporting data to identify issues and drive improvements.

Mansioni

• 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.
• Review, classify, and ensure reportable safety complaints.
• Lead clinical investigations and risk analysis for product safety.
• Mentor and coach the Clinical Product Surveillance team.
• Develop procedures for MDR and adverse event reporting.

Conoscenze

Data analysis

Technical communication

Cross-functional collaboration

Time management

Problem solving

Attention to detail

Training/mentoring others

Formazione

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

Healthcare provider certificate/licensure

Bachelor’s Degree in Nursing

Strumenti

Microsoft Office

Descrizione del lavoro

Medline Industries, LP is seeking a Senior Clinical Safety professional to oversee post-market surveillance, assess incoming complaints, and lead clinical investigations for adverse events. You will prepare MDRs and coordinate international reporting, ensuring timely and accurate communications with health authorities.

With mentorship responsibilities, you will coach the Clinical Product Surveillance team, collaborate with QA and product divisions, and drive risk analyses and design