Vp Of Global Regulatory Affairs

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
 

    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
 

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.

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TRAVEL REQUIRED: 20-30 % 

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