Sr. MDR Program Manager
Teleflex

Expected Travel: Up to 25%

Requisition ID: 6112

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.

Position Summary

The Senior Program Manager is responsible for overall project management to facilitate full compliance with the new European Union Medical Device Regulation (EU MDR). The Senior PM will define and drive strategic objectives to actions and deliverables through methodical planning, resourcing, executing, and controlling projects from start to finish. The PM will take program and project ownership while guiding teams through execution. The PM ensures consistent and compliant practices throughout all phases of the project life cycle and across functional teams. The exceptional PM will cultivate a strong and positive business relationships and team culture to improve the business and the prospects of each project team member.

Principal Responsibilities

• Partner with MDR Business Unit Leads and Teams to ensure a harmonized approach for achieving compliance to EU MDR.
• Lead MDR program for Interventional business unit
• Develop, plan, communicate, deploy, and manage project schedules.
• Maintain project governance.
• Effectively lead and drive project teams in a collaborative environment, completing project deliverables per target timelines and requirements.
• Monitor project budgets, directing the efficient use of resources to effectively complete projects.
• Lead project-related activities of project team members, providing guidance on conformance to established design control procedures.
• Coordinate and facilitate weekly meetings, action items, and follow-up with subject matter experts on expected deliverables
• Prepare project summary reports, develop project plans, identify risk, and communicate mitigation activities.
• Present program status to Management regularly.
• Communicate effectively with executive sponsors and steering committee members to ensure clear expectations, demonstrate progress, and identify issues and countermeasures.
• Partner cross-functionally in business gating process for projects under their responsibility
• Negotiate and resolve conflicts and drive decisions among team / functional members to accomplish project and business goals.
• Define and communicate project resource requirements and negotiate with functional managers to obtain resources necessary to support assigned programs.
• Adhere to all regulatory agency standards, company quality standards and corporate policies.
• Cultivate a high performing work team culture among project core teams.
• Must be able to travel domestically and internationally as business needs demand.
• 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.

Education / Experience Requirements

• BS in technical discipline or equivalent education/experience required
• 10 years of demonstrated experience in project management or project engineering working in a technical discipline, medical device and/or engineering preferred.
• Experience with European Union Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) project or program management
• Minimum 5 years project management experience in the medical device and/or FDA regulated industry
• PMP certified is desirable; at a minimum proficiency with design control standards is required.
• Proficiency in Microsoft Office, specifically Microsoft Project, Powerpoint, Excel

Specialized Skills / Other Requirements

• Must have advanced-level project management and process improvement skills.
• 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
• 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.

© 2021 Teleflex Incorporated. All rights reserved.