MDR Labelling Project Manager

Expected Travel
:
Up to 25%

Requisition : 131

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

— 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.

Work in coordination with cross-functional management as well as Project Team, Project Steering Committee, core team, and stakeholders to achieve overall Labeling that meets MDR (Medical Device Regulation) requirements. Coordinate planning and implementation activities with Manufacturing, Demand Planning, Logistics and Distribution, Commercial Regulatory Affairs and Business Unit representatives. Experienced with project management tools and processes and can manage critical situations and provide professional communication of project status to senior management as well as all team members.

• Define the objectives, requirements, and assumptions necessary to structure a project or activity.
• Plan, schedule, and control activities to fulfill identified objectives applying technical, theoretical, and managerial skills to satisfy project requirements.
• Drive and develop integrated development plan that represents the appropriate level of detail and task interdependency and aligns project tactics with overall project strategy.
• Establish and maintain a high performing team and serve as a project advocate within the organization.
• Lead (coordinate, facilitate, and motivate) the efforts of the individual, team, customer, and other resources associated with Labeling project activities. Acquire alignment in task deliverables and goals.
• Manage the project within the established scope, schedule, and budget while maintaining quality as a top priority.
• Lead risk management within the project team. Ensure risks have appropriate mitigation and develop contingency plans.
• Present to executive leadership, steering committee members, senior management, and department SMEs weekly and monthly project status and elevate risks as necessary.
• Facilitate weekly meetings, take meeting minutes with action items, and follow up with SMEs on expected deliverables.
• Maintain strong documentation of project plans, schedules, tracking metrics, and status reports.

• 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 project management experience in large organizations with national or global operations.
• Knowledge and application of a disciplined project management process
  .
• Six Sigma and PMP certifications a plus.

• Strong skills in Project Management tools.
• Exceptional skills with MS Outlook, SharePoint, Excel, and Power Point presentation.
• Experience with Agile and SAP preferred.
• Exceptional interpersonal and leadership skills. Capability to utilize these skills with a broad spectrum of audiences, ranging from front-line workers to senior level executives.
• Technical aptitude and displayed ability to grasp a general knowledge of multiple disciplines and technologies.
• Strong competencies in strategic…