Scientist (IVD)

Washington D. C., MD

Job ID: 131659 Industry: Medical Device

 

  Scientist (IVD) 

Environment:

Our client is a global leader in diagnostic and reagent healthcare products. They research, develop and manufacture a number of In-Vitro Diagnostic products (IVD). They are in need of a Scientist to perform a gap assessment of their current technical documentation against the new European In-Vitro Diagnostic Regulations (IVDR) and create the plans and protocols to assist in reclassification' s 

Principle Duties and Responsibilities:

The consultant will be experienced in Medical Devices and Pharmaceuticals. They must have experience with IVD' s. They will have a background in Quality and technical documentation.  The client is in the midst of an IVDR project and will be required to do reclassifications of multiple products. There are currently 30+ Technical files that have been identified for remedation. This person will work closely with Regulatory to assure the protocols and technical files are compliant to the new regulations. 

Required:
  • IVD Experience
  • Gap Assessment Experience
  • Validation
  • Design Control
  • Risk Management

Plus:
  • IVDR experience

Job Type: Contract

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