Sr. Director, Strategic Regulatory Affairs and UDI

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 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

PEOPLE MANAGERS: All managers are responsible for the following:
•    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. Effective leaders identify and address skills gaps, ensuring that the team has the right expertise to meet current and future challenges. By aligning talent with organizational needs, leaders build a strong foundation for sustained success and adaptability.

•    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.

The pay range for this position at commencement of employment is expected to be between $203,000 - $253,000, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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Working Conditions / Physical Demands

TRAVEL REQUIRED: Up to 25%

WORKING ENVIRONMENT:
☒ Office/Professional        ☐ Plant/Manufacturing    ☐ Remote/Field     ☐ Laboratory