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Sr. Director, Strategic Regulatory Affairs and UDI
**Date:** Jul 23, 2026
**Location:** Morrisville, NC, US
**Company:** Teleflex
**Expected Travel** : Up to 25%
**Requisition ID** :14016
**About Teleflex Incorporated**
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit **teleflex.com** .
**Global Operations -** Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
**Position Summary**
The Senior Director, Strategic Regulatory Affairs & UDI provides leadership and oversight for global regulatory operations, regulatory systems, unique device identification (UDI), regulatory data governance, import/export regulatory compliance support, and regional Regulatory Affairs and Quality functions.
This role is accountable for establishing organizational strategy, operational excellence, governance frameworks, and organizational capability across multiple regulatory and compliance disciplines. The position leads a global organization through a team of managers and functional leaders and serves as a key partner to Regulatory Affairs, Quality, Supply Chain, Manufacturing, Information Technology, Commercial, and Executive Leadership teams to ensure regulatory compliance, support global market access, and enable business growth.
This position has flexibility to be based at our Morrisville, NC USA, Maple Grove, MN USA, or Athlone, Ireland office.
**Principal Responsibilities**
Organizational Leadership
- Lead and develop global teams responsible for Regulatory Operations, UDI, Regulatory Systems, Regulatory Data Management, Import/Export Regulatory Support, and Regional Regulatory Affairs and Quality functions.
- Establish organizational priorities, performance objectives, and resource strategies aligned with business goals.
- Build organizational capability through talent development, succession planning, coaching, and performance management.
- Demonstrates innovating thinking and challenges conventional approaches to solve complex business problems
Strategic Regulatory Operations & Governance
- Provide strategic leadership and governance for regulatory operational processes supporting global market access, global product lifecycle management, and regulatory compliance activities.
- Lead global team of regulatory subject-matter experts in support of cross-business unit, cost-improvement and corporate initiatives.
- Establish and maintain scalable processes, operating models, performance metrics, and governance frameworks that support operational excellence.
- Monitor organizational performance and drive continuous improvement initiatives to enhance efficiency, compliance, and business effectiveness.
UDI, Regulatory Data & Systems Leadership
- Provide strategic oversight of global UDI, regulatory data governance, and regulatory systems activities.
- Ensure effective governance, data integrity, and compliance with applicable regulatory requirements.
- Lead digital transformation and process optimization initiatives that improve regulatory capabilities and business performance.
Regional & Global Compliance Oversight
- Provide leadership and oversight for Canadian Regulatory Affairs and Quality organization.
- Ensure effective execution of regulatory compliance activities through functional leadership teams and support resolution of significant regulatory, quality, and compliance issues.
- Partner with Supply Chain, Trade Compliance, and Operations organizations to support compliant global product distribution and market access.
Cross-Functional & Executive Leadership
- Partners with senior leaders across Regulatory Affairs, Quality, Supply Chain, Operations, Information Technology, and Commercial functions to achieve enterprise objectives.
- Lead complex cross-functional initiatives and commun
About Teleflex