Regulatory UDI Operations Specialist

We are seeking a Regulatory UDI Operations Specialist Associate to support UDI program implementation and compliance with FDA and global regulations in the medical device industry. This role collaborates with Regulatory Affairs, Supply Chain, R&D, QA, and Marketing to ensure accurate UDI data management.

Key Responsibilities:

• Collect, verify, and enter UDI data into internal/external databases.
• Ensure data accuracy between labels and master UDI data.
• Assist in implementing UDI-compliant solutions and updating SOPs.
• Support process improvements for regulatory data accuracy.
• Provide training on UDI/GUDID requirements.

Qualifications:

• 1+ years of UDI experience in medical devices.
• Experience with ERP systems (SAP/Oracle).
• Strong attention to detail, communication, and organizational skills.

Join a growing team in the medical device industry today!

For California Applicants:

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO) , and the California Fair Chance Act (CFCA).

This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.