Regulatory UDI & Data Syndication Lead

Job Title: Regulatory UDI & Data Syndication Lead
Location: Remote (Preferred: Twin Cities, MN)

Function: Regulatory Affairs, Quality & Product Stewardship (RAQPS)

Position Summary

• The Regulatory UDI & Data Syndication Lead is responsible for leading Solventum's global UDI, regulatory syndication, and regulatory product data compliance activities. This role serves as the operational owner for customer syndication, regulatory UDI submissions, and regulatory data governance across key global markets.
• The successful candidate will lead critical initiatives including EUDAMED, FDA GUDID, SWISSDAMED, TGA, customer syndication, GTIN strategy and governance, and regulatory product data management while providing leadership to a global team supporting regulatory compliance activities.

This role requires a strong combination of regulatory knowledge, project leadership, data management, stakeholder engagement, and operational execution.

Key Responsibilities

Regulatory UDI Program Leadership

• Lead global UDI compliance activities.
• Manage product submissions for: EUDAMED, FDA GUDID, TGA, SWISSDAMED, 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: GTINs, Product hierarchy, Regulatory attributes, 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

Required Experience

• 5+ years of experience in: Regulatory Affairs, UDI, Product Lifecycle Management (PLM), Data governance, Regulatory operations, Quality systems
• Experience with: FDA GUDID, EUDAMED, GTIN management, Regulatory product registrations, Regulatory data syndication
• Demonstrated project leadership experience.
• Experience leading cross-functional teams and stakeholders.

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

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.

Education:

• Bachelor's degree in: Regulatory Affairs OR Engineering OR Life Sciences OR Quality OR Supply Chain OR Information Systems OR Data Analytics OR Related field Master's degree preferred.