UDI Regulatory Operations Specialist

Medline Industries, LP; Northfield (MN); Presencial; USD 67.000 - 101.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k) contributions

Paid time off

Descripción de la vacante

Medline Industries, LP is seeking a UDI Regulatory Coordinator to support implementation and ongoing maintenance of the UDI program. The role involves data collection, verification, and alignment with FDA regulations across multiple sites and teams.

You will collaborate with Regulatory Affairs, QA, Supply Chain, and R&D to ensure accurate labeling, GUDID submissions, and compliant documentation. Strong attention to detail and cross-functional communication are essential.

Formación

• Bachelor’s degree in life sciences.
• 1 year of experience in a Quality or Regulatory role for a regulated industry.
• Detail oriented with strong communication, organizational, analytical, and critical thinking skills.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).

Responsabilidades

• Collect UDI data attributes from various sources.
• Verify and enter UDI data into databases per FDA regulations.
• Ensure data accuracy between labels and master UDI data.
• Collaborate with cross-functional teams across multiple sites for regulatory submissions and labeling/UDI database entries.
• Assist Regulatory Affairs and other teams in implementing UDI compliant solutions.
• Support QMS integration projects related to medical device labeling/UDI compliance.
• Update and maintain SOPs related to UDI/GUDID and other Quality documents.
• Coordinate timely review and implementation of these documents.
• Compile and review documentation for product development, manufacturing, and quality per UDI regulatory standards.
• Communicate status of deliverables to internal/external teams.
• Provide training on UDI/GUDID to various groups to ensure data integrity and understanding of requirements.
• Identify and propose process improvements to enhance data flow to GUDID and other regulatory submissions.

Educación

Bachelor’s degree in life sciences

Herramientas

MS Office Suite (Word, Excel, PowerPoint, Outlook)

Descripción del empleo

Medline Industries, LP is seeking a UDI Regulatory Coordinator to support implementation and ongoing maintenance of the UDI program. The role involves data collection, verification, and alignment with FDA regulations across multiple sites and teams.

You will collaborate with Regulatory Affairs, QA, Supply Chain, and R&D to ensure accurate labeling, GUDID submissions, and compliant documentation. Strong attention to detail and cross-functional communication are essential.