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Project Manager I Jobs

Company

Intellectt Inc
Address Plymouth, MN, United States
Employment type CONTRACTOR
Salary
Category Medical Equipment Manufacturing,Biotechnology Research,Pharmaceutical Manufacturing
Expires 2024-02-28
Posted at 8 months ago
Job Description
Skills Looking For


  • Project manager I for regulatory intelligence.
  • Critical thinking, excellent time management and problem-solving skills.
  • This individual's focus is going to be on EU MDR.
  • IT implementation exp is a plus.
  • Demonstrated Technical and Project management skills and appropriate judgment for these types of programs.
  • Interfacing with the functional customers on any process gap, regulation interpretation, and making sure to integrate the lost phases into the quality system.
  • Strong communication skills are required as they will need to interact with various members at different levels from both up and down.
  • PMP certification is highly preferred but not a requirement.
  • Responsible for helping to drive major regulatory changes into the organization across all divisions in businesses.
  • One of the key deliverables for this program is the implementation of EUDAMED. This is a recording system of data that can be used for competent authorities and users and it contains a number of different modules from system administration to device registration. They need to ensure that these processes are associated with accurate IT functionality. Some exp on this tool will be a plus.
  • Med device exp is a must.
  • End to End EU MDR implementation experience will be a big plus. But the manager is more concerned about project management experience.
  • The ideal candidate must have led several highly complex projects from beginning to end.
  • They will be responsible for project management for Abbott Medical devices in the implementation of the EU MDR to the final stage of EU Certification process and international roller process; This person will be responsible for planning and directing those schedules, and monitoring the program from initiation to delivery.
  • Responsible for driving the completion of the strategies that they might need to execute this and to update executive management on the progress.