UDI Regulatory Operations Specialist (Hybrid)

Medline; Northfield Township (IL); Híbrido; 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 in Northfield, Illinois is seeking an Associate Regulatory UDI Operations to support the implementation and ongoing maintenance of the UDI program, ensuring FDA and related regulatory compliance across labeling and data systems.

You will collect UDI data attributes, verify accuracy between labels and the master UDI data, and work with cross‑functional teams (Supply Chain, R&D, QA, Marketing) to prepare regulatory submissions and UDI database entries.

Formación

• Bachelor’s degree in life sciences (preferred).
• 1+ year in quality or regulatory role in a regulated industry preferred.
• Strong attention to detail and communication skills required.

Responsabilidades

• Collect UDI data attributes and verify data accuracy.
• Work with cross‑functional teams to align information for regulatory submissions and UDI entries.
• Update SOPs and quality documents related to UDI/GUDID.
• Assist in training teams on UDI/GUDID to ensure data integrity.

Conocimientos

Detail-oriented

Communication

Organizational skills

Analytical skills

Critical thinking

Time management

Educación

Bachelor’s degree in life sciences

Herramientas

MS Office Suite

Descripción del empleo

Medline in Northfield, Illinois is seeking an Associate Regulatory UDI Operations to support the implementation and ongoing maintenance of the UDI program, ensuring FDA and related regulatory compliance across labeling and data systems.

You will collect UDI data attributes, verify accuracy between labels and the master UDI data, and work with cross‑functional teams (Supply Chain, R&D, QA, Marketing) to prepare regulatory submissions and UDI database entries.