Job Details

  • Title: Project Manager
  • Code: RCI-5134
  • Location:
  • Posted Date: 09/15/2020
  • Duration: 6 Months
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  Job Description


Candidates will be working remote foreseeable future. Person could remain remote for the duration of the assignment.

  • Running remediation activities in a regulatory affairs
  • Working with 15-20 people delivering documentation for product remediation
  • Project plan
  • Schedule
  • Hold weekly meetings with core team to drive timelines and completion of times
  • This is not an IT PM role. Not following agile or waterfall. Not systems based
  • PM is highly desired. In a technical field of regulated environment
  • High level of communication skills
  • Medical device or pharma PM experience
  • Technical expertise
  • Development work to execute a product launch
  • Strong communicator
  • Highly organized
  • MS project, SharePoint, MS Suite that includes outlook
  • This person will be required to report out to leadership. (manager director level)
  • BA is required
  • 5+ years of experience in a PM leadership role in a regulated environment

Top Skills:

  • Focusing on leadership on small projects and leading a team through successful milestones
  • Technical background
  • Medical/Pharma experience

Job Duties:

  • Manages complex device projects within the B/U.
  • Assures the development of multi-level project planning to achieve short and long-term business objectives
  • Develops, tracks and reports on all key project deliverables.
  • Keeps senior management team informed of progress and issues.
  • Develops and communicates key performance indicators (cost/schedule/technical/quality) for projects.
  • Ensures project teams have appropriate resources to perform assigned tasks.
  • Interfaces with appropriate internal and external resources to ensure intellectual property is protected.
  • Reviews protocols and reports to support regulatory submissions.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.