UDI Regulatory Operations Specialist

Medline; Northfield Township (IL); Presencial; USD 67.000 - 101.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Descripción de la vacante

Medline Industries, LP is seeking a Regulatory/U DI data coordinator to support and execute operational elements of the UDI program implementation and maintenance. The role involves collecting and verifying UDI data attributes, ensuring accuracy across labeling and master data, and coordinating with cross-functional teams at multiple sites to support regulatory submissions and labeling.

The position requires a Bachelor’s degree (life sciences preferred) and at least 1 year in a Quality or

Formación

• Bachelor's degree in life sciences or related field.
• 1 year of experience in a Quality or Regulatory role for a regulated industry.
• Strong attention to detail and ability to communicate clearly.

Responsabilidades

• Collect UDI data attributes from multiple sources and verify entries in databases for FDA compliance.
• Ensure data accuracy between labels and master UDI data in line with FDA guidelines.
• Collaborate with cross-functional teams at multiple sites to align regulatory submissions and UDI entries.

Conocimientos

Communication skills

Organizational skills

Analytical skills

Critical thinking

MS Office

Educación

Bachelor's degree (life sciences preferred)

Herramientas

MS Office

Descripción del empleo

Medline Industries, LP is seeking a Regulatory/U DI data coordinator to support and execute operational elements of the UDI program implementation and maintenance. The role involves collecting and verifying UDI data attributes, ensuring accuracy across labeling and master data, and coordinating with cross-functional teams at multiple sites to support regulatory submissions and labeling.

The position requires a Bachelor’s degree (life sciences preferred) and at least 1 year in a Quality or