Sr. Director, Strategic Regulatory Affairs and UDI
$203k - $253kTeleflex
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 problemsStrategic 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 communicate strategic priorities, risks, and opportunities to executive leadership.• Influence organizational decision-making through data-driven recommendations and strategic insight.• Adhere to and ensure compliance with the Teleflex Code of Ethics, all company policies, rules, and procedures.• Complete other duties and tasks 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.• Experience leading geographically dispersed teams and organizations preferred.
- Exceptional leadership skills and proven experience in leading, advising, inspiring, educating, and developing high-performance teams. • Excellent interpersonal and communication skills with the ability to communicate effectively across all areas of the business.• Strategic thinking and business acumen.• Executive presence and influence.• Change management and transformation leadership.• Cross-functional collaboration and stakeholder management.• Strong analytical and problem-solving capabilities.• Advanced skills in the Microsoft office suite.Specialized Skills / Other Requirements
- Cross-functional Alignment - Building cross-functional relationships and alignment is essential to driving coordinated, organization-wide success. Leaders must foster open communication, trust, and mutual respect across teams to break down silos and ensure shared understanding of goals and priorities. It’s critical to actively engage stakeholders, listen to diverse perspectives, and align efforts through clear direction and shared accountability. By promoting collaboration and joint problem-solving, leaders help teams move in sync and deliver integrated solutions that support strategic objectives.
- Continuous Improvement - Driving continuous improvement means fostering a culture where learning, innovation, and adaptability are part of everyday work. Leaders must encourage teams to challenge the status quo, identify inefficiencies, and implement solutions that enhance performance and outcomes. It’s critical to use data and feedback to inform decisions and to recognize both progress and lessons learned. By modeling a growth mindset and rewarding initiative, leaders empower teams to take ownership of improvements and contribute to sustained organizational excellence.
- Culture and Values – Upholding and modeling organizational culture and values is essential to building trust, engagement, and a sense of purpose. Leaders must consistently demonstrate integrity, inclusivity, and accountability in their actions and decisions, setting the tone for how others show up at work. It's critical to create an environment where individuals feel respected, supported, and empowered to contribute authentically. By recognizing and reinforcing behaviors that align with core values, leaders help embed the culture into daily operations and long-term success.
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