Regulatory UDI & Data Syndication Lead

Job#: 3046934

Job Description:
Regulatory UDI & Data Syndication Lead

Remote | Healthcare/Medical Device Industry Experience Required
Overview

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. The successful candidate will be comfortable performing detailed regulatory analysis, supporting UDI compliance activities, evaluating change management documentation, managing GTIN strategy decisions, and coordinating data syndication efforts. Experience within the healthcare, medical device, life sciences, or other regulated industries is strongly preferred.

Top 3 Required Skills

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

Key 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.

Required Qualifications

• 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.

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

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Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.

Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

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