Regulatory UDI & Data Syndication Lead

Remote position in the healthcare/medical device industry.

About the role

We are seeking an experienced Regulatory UDI & Data Syndication Lead to support global regulatory compliance, product data management, and customer data syndication initiatives for a large healthcare organization. This role will serve as a key contributor within the Regulatory Affairs and Product Stewardship function, helping ensure the accuracy, governance, and compliance of regulatory product data across multiple global markets. The ideal candidate will possess strong hands-on experience with Unique Device Identification (UDI), GTIN governance, regulatory data management, and data syndication processes. This individual will work closely with cross-functional stakeholders across Regulatory Affairs, Quality, Operations, Commercial, and IT teams to support regulatory submissions, assess product changes for compliance impact, manage customer data requests, and maintain the integrity of critical product and regulatory data. This is a highly operational role focused on execution rather than people management.

Top 3 Required Skills

• UDI (Unique Device Identification)
• GTIN Governance/Strategy
• Regulatory Data Syndication

Responsibilities

• Manage UDI activities across global regulatory databases (FDA GUDID, EUDAMED, and other applicable systems).
• Perform UDI impact assessments and regulatory change analysis.
• Evaluate change management documentation (CMPs) and determine regulatory data impacts.
• Support GTIN governance and determine when GTIN changes are required.
• Extract, validate, and syndicate regulatory product data to customers and external partners.
• Maintain regulatory product data accuracy and compliance.
• Partner with Regulatory Affairs, Quality, IT, and business stakeholders.
• Support reporting, metrics, and process improvement initiatives.

Requirements

• 5+ years of experience in Regulatory Affairs, UDI, Regulatory Operations, or Product Data Management.
• Experience with UDI compliance and regulatory product data.
• Experience with GTIN management and data syndication.
• Healthcare or medical device industry experience required.
• Strong SQL skills for data extraction and analysis.

Preferred Qualifications

• Experience with FDA GUDID and EUDAMED.
• GS1 standards and GTIN governance experience.
• Power BI or Tableau experience.
• Experience with PLM, RIM, or MDM systems.

Additional Notes

Highly hands-on role. Leadership experience is a plus but not required. Candidates should be comfortable performing day-to-day UDI and syndication activities independently. Initial 6-month engagement with strong potential for extension.

Benefits

• Supplemental medical, dental, vision, life, and disability insurance plans.
• Employee Stock Purchase Program (ESPP).
• 401K program with company match after 12 months of tenure.
• Health Savings Account (HSA) on the HDHP plan.
• SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions.
• Corporate discount savings program and other discounts.
• On-demand training program and access to certification prep, technical and leadership courses/books/seminars after 6+ months of tenure.
• Certification discounts and association perks (e.g., CompTIA, IIBA).
• Dedicated customer service team and certified Career Coach.