IVDR Project Manager (Tech File Risk Remediation)

Boston, MA

Industry: Medical Device Job Number: 133352

In-Vitro Diagnostic  Project Manager

Background:

Our client is a global manufacturer of In-Vitro Diagnostic products. They are currently in need of a Project Manager to drive the Risk Management  portion of our client' s  EU IVDR compliance initiative (European In-Vitro Diagnostics Regulation).

Duties/Responsibilities:

The consultant will come from a strong Project Management background, with a proven track record of driving large-scale, global projects from start to finish. In addition, this individual should have a strong background in Risk Management, and Technical File Remediation.  This individual will oversee a team of executor-level Risk Management contractors to remediate/update the client' s Technical Files based upon IVDR for Risk. 

The primary responsibility of this Project Manager will be to create a project plan, and ensure their teams' deliverables are scheduled and completed according to the project plan.  The Project Manager should also be comfortable creating and delivering presentations to senior management on project updates.

It would also be a huge plus if this individual has familiarity with EU IVDR, and an understanding of Technical Files, Design Controls, International Regulations, and/or Risk Management. It would also be highly preferred if this individual has a PMP Certification.

Required:
  • Project Management
  • In-Vitro Diagnostics
  • Technical File Remediation
  • Risk Management

Preferred:
  • PMP Certification
  • Global Project Management
  • Familiarity with EU IVDR

Job Type: Contract  

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