Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Sr. Director, Strategic Regulatory Affairs and UDI

$203k - $253k
Full-time

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 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
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. #LI-EB1Working Conditions / Physical Demands TRAVEL REQUIRED: Up to 25% WORKING ENVIRONMENT:☒ Office/Professional ☐ Plant/Manufacturing ☐ Remote/Field ☐ LaboratoryAt Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front. Teleflex Incorporated 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 you require accommodation to apply for a position, please contact us at: View phone number on click.appcast.io or View email address on click.appcast.io. Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. © 2026 Teleflex Incorporated. All rights reserved.

Vacancy posted 9 hours ago
Similar jobs that could be interesting for youBased on the Sr. Director, Strategic Regulatory Affairs and UDI in Durham, NC vacancy
  •  ...About the job Senior/Director - Regulatory Affairs Director / Senior Director, Regulatory Affairs About the Role The company is...  ...fully onsite position. Responsibilities Supply strategic regulatory guidance for global drug development efforts,... 
    Senior
    Worldwide

    Implaion Recruiting

    Durham, NC
    4 days ago
  • $190k - $260k

     ...accommodation or an alternative application process. Director (Senior Director), Regulatory Affairs Full Time Durham, NC, US 11 days ago Requisition ID:...  ...'s experience. Responsibilities Provide regulatory strategic input for global drug development projects, including... 
    Senior
    Full time
    Local area
    Worldwide

    Shattuck Labs, Inc.

    Durham, NC
    17 hours ago
  • $190k - $260k

    Shattuck Labs, Inc. is seeking a Director (Senior Director), Regulatory Affairs in Durham, NC. This role requires a minimum of 8 years of regulatory experience in the bio/pharmaceutical industry and involves overseeing global regulatory strategies for drug development.... 
    Senior

    Shattuck Labs, Inc.

    Durham, NC
    17 hours ago
  •  ...amazing World Class Culture! NeoGenomics is looking for a Sr. Manager, Category Management & Strategic Sourcing who wants to continue to learn in order to...  ..., IT, Facilities, HR, Marketing, Legal, Quality/Regulatory, and Operations leaders to align indirect sourcing strategies... 
    Senior
    Contract work
    Temporary work
    Work experience placement
    Work at office

    NeoGenomics Laboratories

    Durham, NC
    4 days ago
  • $186.3k

    Job Overview The Senior Medical Director provides strategic medical and scientific subject matter experience and expertise to IQVIA in the specialty/subspecialty or therapeutic area for which they have first hand knowledge informed by training, experience and expertise.... 
    Senior
    Full time
    Part time
    Immediate start

    NCBiotech

    Durham, NC
    2 days ago
  • Sr Director Market Access Strategy, Access Optimization Location: Philadelphia (preferred) or Durham, NC The Sr Director of GSK Market...  ...products Collaborate across Market Access on the development of strategic access plans for in-line brands, new assets, pipeline products... 
    Senior
    Contract work
    Local area

    GlaxoSmithKline

    Durham, NC
    1 day ago
  • IQVIA is seeking a Senior Account Manager in Durham, NC to lead client relationships and ensure strategic campaign success. You will leverage your expertise in programmatic advertising to manage campaigns, analyze performance, and provide actionable insights to clients.... 
    Senior

    IQVIA

    Durham, NC
    17 hours ago
  • $122.6k - $341.3k

     ...Responsibilities Planning Cycle: Provide support for the annual R&D strategic planning cycle. Business Intelligence: Lead business intelligence efforts including market assessments, segment sizing and growth estimates, competitor assessments, and customer segment analysis... 
    Senior
    Work at office

    IQVIA

    Durham, NC
    1 day ago
  • $140k - $155k

    Piper Companies is hiring a Program Manager for an award-winning company in the Raleigh-Durham Area. The Program Manager will support product-aligned delivery models, requiring a presence in the office three days per week. Ideal candidates will have over 8 years of project...
    Senior
    Work at office
    3 days per week

    Piper Companies

    Durham, NC
    1 day ago
  • A dynamic commercial construction firm in Durham, NC is seeking an Estimator or Preconstruction Manager. This role involves critical pre-construction planning, managing estimates, and overseeing budgets and strategies. Ideal candidates will have over 5 years of experience...
    Senior

    Invoke Staffing

    Durham, NC
    3 days ago
  • IQVIA Argentina in Durham, United States, seeks a Senior Director for Strategic Planning to guide development in the Research & Development Solutions division. This role involves overseeing strategic planning, conducting market intelligence efforts, and facilitating mergers... 
    Senior
    Remote job

    IQVIA Argentina

    Durham, NC
    4 days ago
  •  ...recruiting works in practice? The University Talent team is seeking a Sr. Manager, University Talent Insights and Strategy to lead how we...  ...activities and the rules and regulations of numerous self-regulatory organizations, including FINRA, among others. Those laws and regulations... 
    Senior

    Soteria Reinsurance Ltd.

    Durham, NC
    1 day ago
  • $165k - $220k

     ...health, and we believe we are well positioned to continue leading the advancement of eye health in the future. The Director, Regulatory Affairs leads global regulatory strategy, reporting, compliance, labeling, and regulatory intelligence to support product development... 
    Temporary work
    Work visa

    Bausch + Lomb

    Durham, NC
    1 day ago
  •  ...Job Title: Director, Regulatory Affairs Department: Pharmaceutical Development About Pelthos: Pelthos Therapeutics is a bio-pharmaceutical...  ...as medical device requirements. ~ Ability to think strategically, operationally and tactically to bring regulatory... 
    Work at office
    Local area

    Pelthos Therapeutics

    Durham, NC
    4 days ago
  • $134.4k - $255.4k

    Sr Director/Director, Strategy & Delivery - Ophthalmology Updated: Today Location: Morrisville...  ...Committees. Provides scientific/regulatory oversight and project/therapeutic training...  ...the senior-most operational leader and strategic advisor for top-tier clients, fostering... 
    Senior
    Contract work
    Flexible hours

    Syneos Health, Inc.

    Morrisville, NC
    3 days ago
  • IQVIA LLC in Durham, North Carolina, is seeking a Sr Medical Strategy Director to provide strategic medical and scientific expertise. The ideal candidate will contribute to proposal development, client meetings, and serve as a consultant throughout clinical trials. This... 
    Senior
    Remote job

    IQVIA LLC

    Durham, NC
    17 hours ago
  • $120k - $140k

    The American Institute of Certified Public Accountants is seeking a Senior Manager for Personal Financial Planning. This role entails being the subject matter expert while managing committees and collaborating with partners to promote PFP. You'll represent AICPA and monitor...
    Senior
    Flexible hours

    American Institute of Certified Public Accountants

    Durham, NC
    3 days ago
  • Australia-Employment is looking for a Preconstruction Manager in Durham, NC, to lead the planning and development of construction projects. This role involves estimating, coordinating with professionals, and managing budgets. Ideal candidates will have 5+ years in construction...
    Senior

    Australia-Employment

    Durham, NC
    1 day ago
  • $120k - $140k

     ...and credential. You will report to the Director - Personal Financial Planning as an individual...  ...and PFS Credential. Oversee our strategic task forces based on the latest needs in...  ...questions, credential requirements, and regulatory issues. Be an AICPA ambassador to influence... 
    Senior
    Remote work
    Flexible hours

    American Institute of Certified Public Accountants

    Durham, NC
    3 days ago
  •  ...ensure ongoing adherence to established quality standards and regulatory requirements, playing a key part in advancing our mission and...  ...performance to site leadership and management review forums. Provide strategic site‑level input to support the continuous improvement and... 
    Senior

    Oxford Biomedica

    Durham, NC
    1 day ago
  • Toshiba Global Commerce Solutions is seeking a Sr. Program Manager, Operational Excellence....  ...automation tools Key Responsibilities Strategic Leadership Develop and execute the...  ...Quality Integration Ensure adherence to regulatory and quality standards Partner with Quality... 
    Senior

    Toshiba Global Commerce Solutions

    Durham, NC
    1 day ago
  • $129.3k - $227.3k

     ...future of customer experience together. Role Overview This role sits within the Product Strategy & Operations team and acts as a strategic partner to Product leadership. The team is responsible for shaping growth strategy, driving its execution, and ensuring the insights... 
    Senior
    Work from home
    Flexible hours

    Genesys Cloud Services, Inc.

    Durham, NC
    1 day ago
  • $98.7k - $183.3k

    Novartis Farmacéutica is seeking a Lead Maintenance Planning & CMMS Admin in Durham, NC. In this key leadership role, you’ll manage planning and scheduling for maintenance operations across the campus and ensure system performance. Ideal candidates will possess extensive...
    Senior

    Novartis Farmacéutica

    Durham, NC
    1 day ago
  • $77.91k - $105.13k

    Durham County is hiring a Social Work Program Manager for the Child Protective Services Program within the Department of Social Services. The ideal candidate will manage a comprehensive program, oversee policy development, support program evaluation, and supervise staff...

    Durham County

    Durham, NC
    1 day ago
  • $160k - $170k

     ...Job Overview: The Director, Global Strategic Sourcing, is responsible for leading the strategy, design and development of a world-class strategic...  ..., and value in alignment with Fortrea policies and regulatory requirements. Execution ~ Lead and project manage... 
    Full time
    Contract work
    Part time
    Work at office
    Flexible hours
    3 days per week

    Fortrea

    Durham, NC
    17 hours ago
  • $74.2k - $100.12k

    Durham County is seeking a Tax Auditing Division Manager to oversee the operations of the Personal Property and Compliance Division. Responsibilities include managing audits, supervising staff, and preparing cases for assessment appeals. The ideal candidate will have a ...
    Senior

    Durham County

    Durham, NC
    17 hours ago
  •  ...leadership and peers to ensure training programs are aligned with regulatory requirements, evolving business processes, and innovative...  ...support within a lean Quality, Training, and Compliance (QTC) team* Strategic thinking; ability to analyze opportunities and issues from a... 
    Senior
    Work at office
    3 days per week

    United Therapeutics Corporation

    Durham, NC
    17 hours ago
  • $190k

     ...stakeholder groups to existing teams. Agile advocates. They are well-versed in Agile methodologies and use their expertise to strategically tackle difficult challenges and implement change. Comfortable with ambiguity. They know the path forward isn't always well-... 

    Boston Consulting Group

    Durham, NC
    4 days ago
  • Liquidia Corporation is seeking an Executive Director for Regulatory Affairs, Advertising and Promotion, responsible for strategic and operational management of promotional communications across the product lifecycle. This position collaborates with various teams to ensure... 
    Remote work

    Liquidia Corporation

    Morrisville, NC
    4 days ago
  • $180k - $300k

     ...The role of Strategic Pricing Director is essential to ensure that GSK's innovative pharmaceutical pricing strategies are supported by sustainable, high quality and robust price positioning approaches aligned with the needs of external decision makers responsible for... 
    Local area

    GlaxoSmithKline

    Durham, NC
    6 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Sr. Director, Strategic Regulatory Affairs and UDI. Be the first to apply!