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Project Manager

2 months ago


Santa Clara, United States Intellectt Inc Full time

Job Duties:

  • Manages/directs the activities and people associated with small to large scale projects with a focus on any or several non-IT business applications and disciplines.
  • Manage/direct all facets of single or multiple, multidimensional, mission-critical projects through the Full Project Life Cycle.
  • Collaborate/work with project sponsors, business units and users to identify project scope and focus, develop or monitor project initiatives, implement project requirements/plans/processes/tools, assign/guide/monitor project staff, and assure project success.
  • Deliver quality project solutions to business problems or issues within defined budgets and/or timelines.
  • Provide expert project guidance/support proactively through project completion.
  • Provide tracking, reporting, and presentation to management and users.
  • 1-6 years experience

Note:

  • Job Title: Regulatory Affairs Project Manager
  • Job Roles & Responsibilities: -
  • Support IVDR compliance activities including creation of technical files, post market surveillance activities
  • New product development documentation
  • On market support: regulatory impact assessments, etc…
  • Regulatory operations: BUDI number updates, label reviews, FDA laser report, state manufacturing license etc..