Regulatory UDI & Data Syndication Lead

Key Responsibilities

Regulatory UDI Program Leadership

•             Lead global UDI compliance activities.

•             Manage product submissions for:

o            EUDAMED

o            FDA GUDID

o            TGA

o            SWISSDAMED

o            Other applicable regulatory databases.

•             Maintain compliance with evolving global UDI regulations.

•             Drive remediation and data quality initiatives impacting regulatory compliance.

Data Syndication & Customer Syndication

•             Lead Customer Syndication operations.

•             Manage customer data publication requests.

•             Establish operational priorities and service-level expectations.

•             Monitor backlog, SLA metrics, and customer commitments.

•             Review and approve complex customer syndication submissions.

•             Partner with commercial, customer operations, and regulatory teams.

Regulatory Data Governance

•             Ensure accuracy and integrity of:

o            GTINs

o            Product hierarchy

o            Regulatory attributes

o            UDI data elements

•             Partner with PLM, DataHub (Regulatory Database, RIM, Master Data (MDM), and IT teams.

•             Support regulatory data governance programs and process improvements.

Team Leadership

•             Lead and develop Regulatory Data Syndication resources.

•             Conduct performance management, coaching, and development discussions.

•             Manage workload balancing and resource planning.

•             Establish clear priorities and accountability across the team.

Project & Process Management

•             Lead cross-functional regulatory data projects.

•             Create and maintain project plans.

•             Manage risks, dependencies, and stakeholder communication.

•             Develop data-driven reporting and performance metrics.

•             Present progress and recommendations to leadership.

Risk Management & Escalation

•             Proactively identify regulatory compliance risks.

•             Escalate issues with recommended mitigation plans.

•             Drive resolution of data quality and compliance concerns.

•             Ensure leadership visibility to project status and emerging risks.

Preferred Qualifications

Education

Bachelor''s degree in:

•             Regulatory Affairs

•             Engineering

•             Life Sciences

•             Quality

•             Supply Chain

•             Information Systems

•             Data Analytics

•             Related field

Master''s degree preferred.

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Required Experience

•             5+ years of experience in:

o            Regulatory Affairs

o            UDI

o            Product Lifecycle Management (PLM)

o            Data governance

o            Regulatory operations

o            Quality systems

•             Experience with:

o            FDA GUDID

o            EUDAMED

o            GTIN management

o            Regulatory product registrations

o            Regulatory data syndication

•             Demonstrated project leadership experience.

•             Experience leading cross-functional teams and stakeholders.

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Preferred Experience

•             Medical Device industry experience.

•             GS1 standards and GTIN governance.

•             Regulatory Information Management (RIM) systems.

•             Product Lifecycle Management (PLM) systems.

•             DataHub / Master Data Management platforms.

•             Power BI, SQL, analytics, and reporting tools.

•             Experience managing global regulatory compliance programs.

Key Competencies

•             Regulatory compliance expertise

•             UDI and product data management

•             Team leadership

•             Stakeholder management

•             Project management

•             Data-driven decision making

•             Risk identification and escalation

•             Cross-functional collaboration

•             Process improvement

•             Executive communication

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Success Measures

Success in this role will be measured by:

•             UDI compliance across all required jurisdictions.

•             EUDAMED submission readiness.

•             Customer Syndication SLA performance.

•             Regulatory data quality metrics.

•             GTIN governance effectiveness.

•             Timely risk identification and escalation.

•             Successful leadership of the Data Syndication function.

•             Delivery of regulatory projects and commitments.

•             Development and engagement of team members.