nion Medical Device Regulation (EU MDR) Senior Program Manager

8 - 10 years experience  •  Manufacturing

Salary depends on experience
Posted on 05/23/18
Mansfield, MA
8 - 10 years experience
Manufacturing
Salary depends on experience
Posted on 05/23/18

Careers That Change Lives     The EU MDR Senior Program Manager will report directly into the Vice President of Center Led Quality for Medtronic’s Minimally Invasive Therapy Group (MITG).  This position is responsible for project and program management, including the planning and implementation across all MITG sub-businesses, to facilitate full compliance with the new European Union Medical Device Regulation (EU MDR).   The EU MDR Senior Program Manager 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 programs strategic initiatives while managing tactical activities and partnering effectively with a large and varied group of stakeholders.    The EU MDR Senior Program Manager is accountable for alignment with the associated corporate project management offices, Quality and Regulatory councils, sub-councils, and workstream to drive harmonization across MITG and Medtronic.  In this role, the individual is responsible for ensuring team commitments (scope, schedule and budget) are met and for communicating program status to senior leadership on a regular basis.    

A Day in the Life   In this exciting role as EU MDR Senior Program Manager, you will have responsibility for the following:  

  • Develop thorough understanding of EU MDR requirements as well as subsequent guidance documents and implementing acts.  Provide guidance to the business group on interpretation and impact of the new regulations
  • Identify appropriate resources, assign responsibilities, and manage a direct MITG EU MDR Center-Led team of approximately 5 project managers
  • Establish and maintain program governance
  • Partner with EU MDR subject matter experts (SMEs) regarding common Medtronic interpretation and guidance, deliverables, pace and progress across the organization to ensure a harmonized approach for achieving compliance
  • Collaborate with corporate project team, business units, and regional program leaders, 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; drive multiple project workstreams; 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 MITG business and functions leadership
  • Through the implementation of project management and productivity tool, maintain and track progress and produce applicable reports
  • Partner with other Medtronic program leaders to ensure coordination of activities and timelines, facilitating efficient use of resources
  • Partner with MITG Regulatory and Quality Operations as well as IT project management to develop systems and IT tools requirements to support effective standard processes
  • Work within established EU MDR governance models, identify areas for improvement and manage items related to governance activities
  • Identify, recommend and drive execution of approved process improvement initiatives to promote value capture efficiencies
  • Develop, plan, communicate and deploy program schedules.  Responsible to meet project phase deliverables and milestones

Must Have: Minimum Requirements  EDUCATION REQUIRED:  

  • BS/BA degree in the Sciences, Business or Project Management, Engineering, or other related fields.  Advanced degree in Business or Project/Program Management preferred

 YEARS OF EXPERIENCE: 

  • 8+ years of project management and/or program management in the medical industry or transferable skills from a regulated industry

 SPECIALIZED KNOWLEDGE REQUIRED: 

  • Must have expert project/program management and process improvement skills. 
  • Must have Lean training
  • Must have experience in the medical device industry or related regulated industry
  • Broad business knowledge and ability to link customer needs with business processes
  • Demonstrated capacity for strategic thinking, project planning and project management
  • Experience driving initiatives and change management across business units
  • 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 program 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 and budgets
  • Exceptional program/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

    To be considered for this role, please ensure the minimum requirements are evident on your resume.     Nice to Have ~ Preferred Requirements  

  • European Medical Device Directives (MDD/AIMDD) and CE Mark process experience
  • Technical Files or Design Dossiers experience
  • Regulatory Affairs, Quality Design, or Quality System/Compliance experience
  • Experience managing global initiatives in a matrix organization
  • Green or Black Belt Certification

180007DN

Not the right job?
Join Ladders to find it.
With a free Ladders account, you can find the best jobs for you and be found by over 20,0000 recruiters.