MDR Project Manager
Our client a global medical device company is currently seeking an MDR Project Manager to join their team. The MDR Project Manager will be responsible for project management, including the planning and implementation, to facilitate full compliance with the new European Union Medical Device Regulation (EU MDR). MDR Project Manager will provide direction and understanding on the regulatory requirements of the MDR to the business unit as well as responsible to influence a wide range of functions and departments to drive the project’s strategic initiatives while managing tactical activities and partnering effectively with a large and varied group of stakeholders. Collaboration with shared services partners to ensure effective planning and delivery of requirements to meet product compliance deadlines. Ensure team commitments (scope, schedule and budget) are met. Communicate project status to Snr Project Manager 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 Lead and Team regarding common interpretation and guidance, deliverables, pace and progress to ensure a harmonized approach for achieving compliance
• Collaborate with project team, business units, and workstream/shared services 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 program leadership 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 tools, 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
• Partner with Regulatory and Quality Operations as well as IT project management to develop systems and IT tools requirements to support effective standard processes
• Facilitate regularly scheduled meetings, take meeting minutes with action items, and follow up with SMEs on expected deliverables.
Education / Experience:
• Bachelor’s degree in a business or science discipline or equivalent education/experience required.
• Minimum 2 years project management experience in the medical device and/or FDA regulated industry.
• Minimum 5 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.
• Must have Regulatory Affairs experience/knowledge and relevant experience in 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
For further information please contact James Cassidy 0860204322 or mail firstname.lastname@example.org