Sr. Director, Strategic Regulatory Affairs and UDI

Overview 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 solutions in anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. Teleflex is the home of Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Ruësch, UroLift and Weck – trusted brands united by a common sense of purpose. For more information, please visit teleflex.com. Global Operations is a complex and diverse organization within the company responsible for product fulfilment to all customers from end to end. We focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. 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 establishes organizational strategy, governance frameworks, and capability across multiple regulatory and compliance disciplines. The position leads a global organization through a team of managers and functional leaders and partners with Regulatory Affairs, Quality, Supply Chain, Manufacturing, Information Technology, Commercial, and Executive Leadership to ensure regulatory compliance, support global market access, and enable business growth. This position can be based in Morrisville, NC, USA; Maple Grove, MN, USA; or Athlone, Ireland. 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 innovative 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, 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 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; partner with Supply Chain, Trade Compliance, and Operations to support compliant global product distribution and market access. Cross-Functional & Executive Leadership: Partner with senior leaders across Regulatory Affairs, Quality, Supply Chain, Operations, Information Technology, and Commercial to achieve enterprise objectives; lead complex cross-functional initiatives and communicate priorities to executive leadership; influence decision-making with data-driven recommendations; adhere to the Teleflex Code of Ethics; complete other duties as assigned. Education / Experience Requirements Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related discipline required; Advanced degree preferred. Minimum 12 years of progressive leadership experience within Regulatory Affairs, Regulatory Operations, Quality, Compliance, Medical Device Operations, Healthcare Operations, or related regulated industries. Demonstrated success leading managers and complex, multi-functional organizations. Experience establishing governance frameworks, operating models, and organizational strategies. Experience leading large-scale process improvement, systems implementation, or business transformation initiatives. Experience operating within highly regulated global environments and leading geographically dispersed teams is preferred. Exceptional leadership, communication, strategic thinking, executive presence, change management, cross-functional collaboration, and analytical skills; advanced Microsoft Office skills. Specialized Skills / Other Requirements PEOPLE MANAGERS: All managers are responsible for organizational capability, cross-functional alignment, continuous improvement, and culture and values. Responsibilities include developing skills, fostering collaboration, driving improvements, and modeling core values. Compensation and Benefits The pay range for this position at commencement of employment is expected to be between $203,000 - $253,000; base pay offered may vary by location, knowledge, skills, and experience. The total compensation package includes medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in a 401(k) plan, and various paid time off benefits such as PTO, disability and parental leave, dependent on the position offered. Details of participation in these benefits will be provided if an offer is made. Working Conditions / Physical Demands TRAVEL REQUIRED: Up to 25% Working Environment Office/Professional, with consideration for other appropriate work locations as applicable. Equal Employment Opportunity Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If accommodation is required to apply, contact Teleflex. #J-18808-Ljbffr Teleflex