IVD Program Manager
New York City, NY
IVD Program Manager
Our client is a global manufacturer of In-Vitro Diagnostic products. They are currently in need of a Program Manager to drive the client’ s EU IVDR Compliance initiative (European In-Vitro Diagnostics Regulation) to completion.
The consultant will come from a strong Program/Project Management background, with a proven track record of driving large-scale, global projects from start to finish. The client has already formulated an internal team of SME’ s to perform/execute the technical aspects of the Remediation, such as Technical File/Design Dossier Gap Analysis & Remediation, and other IVDR QA/RA activities, so it will be the responsibility of this Program Manager to ensure deliverables are scheduled and completed according to the project plan. This individual will work with senior management to create an overall project plan, schedule project milestones/deliverable due dates, and ensure deliverables and milestones are completed per the project plan. The Program Manager should also be comfortable creating and delivering presentations/project updates to senior management.
It would be a plus if this individual had a Quality or Regulatory background, but it is not a must, as the client’ s internal team already has strong talent in these areas. This role is a true Program/Project Manager, and the individual selected should have experience managing global projects (specifically within the EU) for a Medical Device or Diagnostics organizations.
It would 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.
- Program/Project Manager
- IVD (In-Vitro Diagnostics) or Medical Device Industry Experience
- Global Project/Program Management
- Remediation Experience
- PMP Certification
- Leading Projects in EU
- Familiarity with EU IVDR
- Quality/`Regulatory Experience
Job Type: Contract