Teleflex VP of Global Regulatory Affairs in Morrisville, North Carolina
VP of Global Regulatory Affairs
Date: Feb 12, 2024
Location: Morrisville, NC, US
Expected Travel : Up to 50%
Requisition ID :9810
About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. 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.
The Vice President of Global Regulatory Affairs is responsible for the management and direction of the Regulatory Affairs function for Teleflex globally. These activities include developing and planning regulatory submission strategy, coordinating the preparation of submissions to regulatory agencies, and acting as the regulatory liaison to cross-functional and interdepartmental support functions. The incumbent will work closely with members of the R&D team, Quality, Global Supply Chain, and Clinical Medical Affairs as well as interact with regulatory agencies and ensure timely preparation of submissions. The role oversees the execution of regulatory strategy development and execution for Teleflex and ensures a collaborative and proactive relationship with global regulatory agencies.
• Has overall responsibility to ensure that the Regulatory Strategic Plan is appropriate and effective to meet the Regulatory and Business goals.
• Sets out a vision, sense of purpose, strategy and goals and objectives which ensures that the team is focused, aligned, engaged, and empowered to meet the Regulatory Affairs and business overall goals.
• Establishes the required governance models and management practices required to ensure that the team meets its goals and objectives.
• Deliver global strategies for worldwide regulatory market authorizations
• Oversees the evaluation and analysis of global trends and regulatory changes in the US and global Interventional BU markets
• Understands and anticipates trends/regulatory changes in market authorizations and related reviews by regulatory bodies. Ensures internal guidelines are maintained to current standards
• Creates and reports Teleflex Regulatory state-of-affairs, metrics and dashboard at management review and other business reviews as needed
• Ensure all regulatory processes and procedures are aligned, harmonized and standardized where possible
• Deliver on Teleflex’s Medical Device Regulation program
Education / Experience Requirements
• Bachelor's Degree required
• 15 years of relevant regulatory and quality systems experience required
• Thorough knowledge of the medical device and biologics development process and regulatory pathways, and demonstrated experience with 510K, PMA, and BLA approvals, as well as other global submission and registration requirements
• Demonstrated ability to interface with FDA and other relevant regulatory authorities
• Excellent organizational, written and verbal communication, project and time management skills needed to drive multiple ongoing projects simultaneously
• Ability to identify and lead projects from conception to completion; understanding of budget and planning process and implementation
• Knowledge of Regulatory agency structure, processes and key personnel
• Results driven and team-oriented with the ability to influence outcomes
• Proven management experience in leading organizations through change and growth
• Ability and desire to work in a highly dynamic organization
• Must be able to innovate, analyze and solve problems and have exceptional attention to detail
Specialized Skills / Other Requirements
Engages with stakeholders in a professional and constructive manner, ensuring that the Regulatory agenda is understood and appreciated by the wider Teleflex team.
•Drives Talent development through sponsorship, coaching, mentoring, development assignments and other formal and informal actions and systems. Ensures that there is a vibrant RA succession pipeline of Talent.
•Leads a diverse group of employees by sustaining an inclusive and empowered team which is constantly developing and adapting to the current and emerging business needs.
Working Conditions / Physical Demands
TRAVEL REQUIRED: 20-30 %
☒ Office/Professional ☐ Plant/Manufacturing ☐ Remote/Field ☐ Laboratory
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose.Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
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