Join a global regulatory operations team supporting critical product data compliance and customer syndication initiatives across multiple markets. This role is ideal for a hands-on leader who can balance regulatory accuracy, cross-functional collaboration, and process improvement in a fast-moving environment.

Responsibilities

• Lead global UDI compliance activities and support submissions to key regulatory databases and platforms.
• Oversee customer syndication operations, including data publication requests, prioritization, backlog management, and service-level tracking.
• Review and approve complex syndication submissions while partnering with commercial, customer operations, and regulatory stakeholders.
• Maintain accurate regulatory product data, including GTINs, product hierarchy, and UDI-related attributes.
• Work closely with PLM, data hub, master data, and IT teams to support data governance and process enhancements.
• Lead a team responsible for regulatory data syndication, including coaching, workload balancing, and performance support.
• Manage cross-functional projects, build project plans, track risks and dependencies, and communicate progress to leadership.
• Monitor compliance risks and drive timely resolution of data quality or submission issues.
• Develop reporting and metrics to measure performance, support decision-making, and improve operational outcomes.

Skills

• Bachelor’s degree in a relevant field such as Regulatory Affairs, Engineering, Life Sciences, Quality, Supply Chain, Information Systems, or Data Analytics.
• At least 5 years of experience in regulatory affairs, UDI, PLM, data governance, regulatory operations, or quality systems.
• Working knowledge of UDI and product registration processes, including FDA GUDID, EUDAMED, TGA, and SWISSDAMED.
• Proven experience leading projects, managing priorities, and coordinating across multiple teams.
• Strong stakeholder communication skills with the ability to provide clear updates and escalate risks appropriately.
• Ability to manage data accuracy, compliance requirements, and operational deadlines with strong attention to detail.
• Comfort working in a team leadership capacity with accountability for coaching and development.
• Analytical mindset with the ability to use data to monitor performance and support improvement efforts.

Preferred Skills

• Medical device industry experience.
• Experience with GS1 standards and GTIN governance.
• Familiarity with regulatory information management and product lifecycle management systems.
• Exposure to data hub or master data management platforms.
• Experience using reporting and analytics tools such as Power BI or SQL.
• Master’s degree in a related field.
• Background supporting global regulatory compliance programs.

Horizontal is committed to fostering an inclusive workplace where diverse perspectives are valued, respected, and welcomed. We believe equity and inclusion strengthen teams, improve outcomes, and help create an environment where everyone can contribute their best work.

By applying for this position, you acknowledge and agree that Horizontal Talent may contact you regarding your application using automated technology, including phone calls, SMS/text messages, or email, which may be delivered by our virtual AI recruiter, Alex.