Regulatory UDI & Data Syndication Lead

Title: Regulatory UDI & Data Syndication Lead
Location: Remote (Preferred: Twin Cities, MN)
Function: Regulatory Affairs, Quality & Product Stewardship (RAQPS)
 
Job Summary:
Seeking an experienced Regulatory Data & UDI Program Manager to lead global UDI compliance, regulatory data governance, product data syndication, and cross-functional regulatory initiatives within the medical device industry.
Key Responsibilities

• Lead global UDI compliance and regulatory data programs across FDA GUDID, EUDAMED, TGA, SWISSDAMED, and other regulatory databases.

• Manage regulatory product submissions, data remediation, and data quality initiatives.

• Lead Customer Data Syndication, including submission requests, backlog, SLAs, priorities, and escalations.

• Govern GTINs, product hierarchies, regulatory attributes, and UDI data elements.

• Partner with PLM, RIM, MDM/DataHub, IT, Regulatory, Quality, and Commercial teams.

• Lead cross-functional projects, manage timelines, risks, dependencies, and stakeholder communications.

• Develop KPIs, dashboards, reporting, and executive-level status updates.

• Identify regulatory and data-quality risks and drive mitigation and resolution.

• Lead, coach, and develop Regulatory Data/Syndication team members.

Required Qualifications

• 5+ years of experience in Regulatory Affairs, UDI, regulatory operations, PLM, data governance, or quality systems.

• Strong hands-on experience with FDA GUDID and EUDAMED.

• Experience with UDI, GTIN management, regulatory product registrations, and data syndication.

• Experience leading cross-functional teams and regulatory projects.

• Strong understanding of product and regulatory data governance.

• Excellent stakeholder management, communication, and problem-solving skills.

Preferred Skills

• Medical Device industry experience.

• GS1 / GTIN standards

• RIM / PLM / MDM / DataHub

• Power BI / SQL / Data Analytics

• Global regulatory compliance experience.

• Bachelor's degree in Regulatory Affairs, Engineering, Life Sciences, Quality, Supply Chain, Information Systems, Data Analytics, or related field. Master's preferred.