Global Lead, Medical Device Vigilance & AE Reporting

Medline; Chicago (IL); Presencial; USD 154.000 - 231.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k) contributions

Paid time off

Descripción de la vacante

Medline Industries, LP seeks a senior leader to drive Medical Device Vigilance and pharmacovigilance programs. You will oversee clinical evaluation, medical event management, ICSR processing, ADR reporting and postmarket safety to ensure global regulatory compliance.

Travel to support inspections may be required. This role leads cross-functional teams, partners with QA/Regulatory, and ensures timely safety reporting across devices, drugs, and consumer products.

Formación

• Education: scientific/clinical background; RN/PharmD preferred.
• Experience in medical device and pharma QMS and safety reporting.
• Minimum 5 years in device/pharma quality management systems.
• 2+ years in people management; regulatory inspections experience.
• Knowledge of FDA postmarket reporting and global inspections.

Responsabilidades

• Lead Medline's Medical Device Vigilance program and team.
• Oversee clinical evaluation, event management, and reporting.
• Ensure timely regulatory reporting and postmarketing safety.
• Manage ICSR/ADR processing and safety coding (MedDRA/IMDRF).
• Coordinate global safety activities and audits with QA/regulatory.

Conocimientos

Medical-event assessment

ICSR processing

Cross-functional leadership

Regulatory interpretation

Travel willingness

Educación

Bachelor's degree in life sciences

Nursing/Pharmacy credential preferred

Herramientas

MedDRA/IMDRF terminology

Microsoft Word

Microsoft Excel

Descripción del empleo

Medline Industries, LP seeks a senior leader to drive Medical Device Vigilance and pharmacovigilance programs. You will oversee clinical evaluation, medical event management, ICSR processing, ADR reporting and postmarket safety to ensure global regulatory compliance.

Travel to support inspections may be required. This role leads cross-functional teams, partners with QA/Regulatory, and ensures timely safety reporting across devices, drugs, and consumer products.