Sr. Director, Strategic Regulatory Affairs and UDI

Teleflex; Athlone; On-site; EUR 90,000 - 120,000; Full time

Job summary

Teleflex is seeking a Sr. Director, Strategic Regulatory Affairs and UDI to provide leadership and oversight for global regulatory operations.

This role requires a Bachelor's degree in a related field, at least 12 years of leadership experience in regulatory affairs, and strong strategic thinking skills. The position offers an opportunity to influence organizational compliance and market access initiatives in a global setting.

Remote flexibility is available for this position based in Athlone, Ireland.

Qualifications

• Minimum 12 years of experience in Regulatory Affairs or related fields.
• Demonstrated success in leading teams and organizations.
• Experience in process improvement and business transformation.

Responsibilities

• Lead global teams for Regulatory Operations and UDI.
• Provide strategic leadership for regulatory compliance.
• Oversee Canadian Regulatory Affairs and Quality.

Skills

Leadership

Strategic thinking

Interpersonal communication

Regulatory affairs expertise

Change management

Education

Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs

Advanced degree

Tools

Microsoft Office Suite

Job description

Sr. Director, Strategic Regulatory Affairs and UDI

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.

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.

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.
• Demonstrate innovative thinking and challenge 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

• Partner 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.

Specialized Skills / Other Requirements

• 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.

People Managers

• Organization Capability – Building organizational capability requires a focus on developing the skills, knowledge, and potential of both individuals and teams. It’s critical to create a culture of learning and growth by providing ongoing development opportunities, mentoring, and feedback.
• 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.
• Continuous Improvement – Driving continuous improvement means fostering a culture where learning, innovation, and adaptability are part of everyday work.
• Culture and Values – Upholding and modeling organizational culture and values is essential to building trust, engagement, and a sense of purpose.

Travel Required

Up to 25%

Equal Opportunity Employer

Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community. If you require accommodation and support to apply for a position, please contact us at [e-mail]. Diversity fosters innovative thinking and entrepreneurship and that’s what we are about at Teleflex.