Global Director, Government Affairs & Regulatory Intelligence
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 Functions – The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
The Government Affairs and Regulatory Intelligence function will focus on empowering further growth of the Teleflex organization through assurance of clear external and internal transparency, engagement and emphasis on shaping, reshaping and influencing government and public sector regulations, policies, guidance’s, decisions, partnerships and other views.
The Director of Government Affairs and Regulatory Intelligence is responsible for partnering with cross functional partners to maintain a scalable, strategy appropriate and maintainable program for Government affairs, Regulatory Advocacy and Intelligence. The role will also work across Geographies and Businesses to establish advocacy positions that are supportive of Teleflex, our patients, and our stakeholders.
The role focuses on identifying, leading, lobbying and executing on Teleflex global regulatory advocacy initiatives and for, or against regulations through venues such as participation in external industry organizations, seminar presentations, development of white paper in alignment with business representation and training as well as, where appropriate, education and guidance to government and regulatory authorities.
Development of the Regulatory Intelligence program through a consistent mechanism of intelligence gathering, interpreting and enforcement, by developing policies and work instructions to assure that Teleflex has adequate documentation in place to operate in accordance with current and changing global regulatory requirements.
Shape a favorable policy environment for advancing the mission of the company.
• Act as the Regulatory Affairs Lead for Government Affairs and Regulatory Advocacy.
• Develop and implement a Corporate Global Government Affairs and Regulatory Advocacy program.
• Advocate directly with government officials. Maintain relationships with regulatory authorities, legislative and executive branches, embassy staff, and others, as required. Communicate with Teleflex partners to ensure full awareness of contacts with government authorities, and to ensure consistent messaging.
• Lead Teleflex global advocacy initiatives, such as training of regulatory authorities, presentations, follow-up on targeted advocacy initiatives, among others.
• Influence public sector decisions to create opportunity for innovation, growth, collaboration and partnerships.
• Author advocacy positions and white papers. Coordinate with cross functional partners and with partners in the Geographies and ensure that the positions meet Teleflex business objectives. Ensure that such documents are distributed internally as appropriate and are retrievable and maintainable.
• Actively participate in trade association working groups, harmonization working group, and represent Teleflex by contributing towards policy shaping and influencing in the competitive environment.
• Compile and/or author Teleflex comments to appropriate draft guidance, proposed rules, trade association positions and other. Ensure that the Teleflex comments are submitted through appropriate channels, such as trade associations, local Teleflex regulatory staff or Government Affairs experts or when appropriate, posted directly to the US docket.
• Develop and maintain an external network of subject matter experts in industry, trade associations, patient advocacy groups, and regulatory agencies, who will be external partners in advocating for effective regulatory policy.
• Act as the Regulatory Affairs Lead for Regulatory Intelligence.
• Develop and implement a corporate global regulatory intelligence gathering and maintaining program.
• Assess gaps with current and changing regulations and assure that accurate and consistent policies are in place and enforced by the respective businesses and geographies.
• Develop and maintain a scalable and appropriate regulatory intelligence gathering mechanism that will also focus on interpreting and enforcing new and changing global requirements. As a result of regulation changes, policies and work instructions may need to be developed to assure that Teleflex has adequate documentation in place to operate according with current and changing global regulatory requirements.
• Provide intelligence to business partners on policy direction, external environment and opportunities for influence.
• Coordinate with Subject Matter Experts across Teleflex to ensure that policies are written or revised as necessary to assure compliance with global regulatory requirements. Address gaps as required by updating policies. Conduct and document routine assessment of Corporate regulatory policies and assure documentation and continuous maintenance of the assessment
• Work within a budget. Conduct the function in a cost-effective, scalable manner.
• Collaborate with stakeholders such as clinical & medical affairs, corporate compliance, business unit general and regulatory leadership
• Provide other departmental support as requested by immediate supervisor.
• Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
• Bachelor or Master’s degree is an applicable scientific field such as regulatory affairs, biology, psychology
• 5-10 years or relevant government affairs experience required
• Minimum of 15 years of professional experience in medical device companies
• Thorough knowledge of global medical device, biologics and in-vitro diagnostic regulatory pathways, submissions and registrations
• At least 7 years’ experience as a functional manager
• Demonstrated ability to interact with regulatory agencies, advocacy groups and government officials
• Experience with the Medical Device Regulation for the EU
• Experience in healthcare and FDA requirements in software design and development
• Experience with pre-submissions, PMA & 510k submissions to the FDA
• Excellent collaboration, communication, leadership, influencing, and presentation skills
• Excellent organizational, written and verbal communications, project and time management skills needed to drive multiple ongoing projects simultaneously
• Ability to interface with internal and external customers in a highly professional manner
• Ability and desire to work in a highly dynamic organization
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: 262-439-1894.
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.
© 2018 Teleflex Incorporated. All rights reserved.
Job posted: 2020-06-05