Expected Travel: Up to 10%
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.
Responsible for project management, including the planning and implementation across all Teleflex Business Units, to facilitate full compliance with the new European Union Medical Device Regulation (EU MDR).
Will provide direction and leadership to a cross-functional team, including subject matter experts (SME), as well as responsible to influence a wide range of functions and departments to drive the projects strategic initiatives while managing tactical activities and partnering effectively with a large and varied group of stakeholders.
Ensure team commitments (scope, schedule and budget) are met. Communicate project status to senior leadership on a regular basis.
• Develop, plan, communicate and deploy project schedules. Responsible to meet project phase deliverables and milestones
• Maintain project governance
• Partner with MDR Business Unit Leads and Teams regarding common interpretation and guidance, deliverables, pace and progress across the organization to ensure a harmonized approach for achieving compliance
• Collaborate with project team, business units, and workstream leads, as well as functional leaders from regulatory, quality and clinical functions to finance, R&D and operations to ensure efficient execution of a shared strategy
• Ensure overall compliance; promote creative solutions; ensure on-time completion of individual tasks and project workstream goals
• Support the development of harmonized business processes and procedures for execution and compliance with EU MDR
• Communicate effectively with executive sponsors and steering committee members to ensure clear expectations, demonstrate progress and identify issues. Provide progress updates and regular reporting to business and functions leadership
• Through the implementation of project management and productivity tool, maintain and track progress and produce applicable reports
• Partner with other project leaders to ensure coordination of activities and timelines, facilitating efficient use of resources to ensure compliant deliverables
• Partner with Regulatory and Quality Operations as well as IT project management to develop systems and IT tools requirements to support effective standard processes
Education / Experience Requirements
• Bachelor's degree in a business discipline or equivalent education/experience required.
• Minimum 2 years project management experience in the medical device and/or FDA regulated industry.
• Minimum 7 years regulatory experience with demonstrated global knowledge.
• Knowledge and application of a disciplined project management process.
• Six Sigma, RAC or PMP certifications a plus.
Specialized Skills / Other Requirements
• Must have strong medical device regulatory experience, including change review and regulatory impact assessments.
• Excellent understanding of regulatory processes for registrations and modifications in a Global environment.
• Strong influence management skills. Demonstrated ability to work cooperatively at all levels in a matrix organization to build and maintain the positive relationships required to accomplish project goals
• Excellent verbal/ written communication and presentation skills. Demonstrated ability to succinctly and accurately communicate to various levels of management and across the organization
• Ability to support multiple projects and balance priorities, work independently or collaboratively to determine and develop solutions
• MS Project, Excel, PowerPoint, SharePoint
• Exceptional facilitation, analytical, planning, organization and time management skills to effectively execute project plans
• Project/project management skills; knowledge of process and project planning best practices
• Excellent decision-making skills. Ability to negotiate and balance decisions and manage competing priorities across multiple functional areas
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.
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