Project Manager

4 weeks ago


Irvine, United States INTELLECTT INC Full time

Role: Program Manager III

Location: Irvine, California, United States

Duration: 12 Months

Requirements:

  • Ability to work in a fast pace, high visibility environment
  • Demonstrated success leading and managing cross-functional teams
  • Strong problem-solving skills
  • 5+ years managing compliance, remediation, or new product development projects within the medical device industry
  • Preferred: Hands-on experience with EU MDR or large remediation projects PMP certification

Scope of Engagement:

  • EU MDR Program Management Support
  • Assist in the following activities under the direction of Senior Program Manager:
  • Develop a robust timeline and plan for the overall program.
  • Development or improvement of program processes to drive program efficiency
  • Update program trackers and program update reports
  • Take meeting minutes
  • Assist with PMO deliverables for program health improvement initiative
  • Take on project management remediation process which includes coordinating with program workstream leaders to manage 1 Class II/III Submissions
  • This role is reporting directly to Senior Program Manager, Strategic Initiatives on a team of project managers supporting Integras EU MDR Program.
  • You will be responsible to support the Program Manager directly in the implementation and maintenance of newly developed program strategies and initiatives including but not limited to:
  • Risk based prioritization of program execution
  • Revision of program plans and milestones according to prioritization
  • Implementation of Program changes
  • Development and maintenance of program risk logs
  • Development and maintenance of program decision logs
  • Development and maintenance of program timeline
  • Facilitating process development meetings
  • Remediation processes and associated training materials
  • Steering committee presentations
  • Meeting note taking and scheduling
  • Identification and timely escalation of project risks to management
  • Working with the team to develop risk mitigations plans
  • Must be able to connect with cross functional teams in French and English
  • Managed programs to ensure that implementation and prescribed activities are carried out in accordance with specified objectives.
  • Plans and develops methods and procedures for implementing programs, directs and coordinates program activities, and exercises control over personnel responsible for specific functions or phases of programs.
  • HS Diploma or GED is required.
  • 7+ years of experience.

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