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Regulatory Affairs Specialist – IVD REF: 862

This is a senior, specialist opportunity for an RA professional with a background in precision medicines. This is a long-term client engagement with a global biopharmaceutical company, based in the US or EU.

  • Experience working on both therapeutics and in vitro diagnostic medical devices (IVDs) in the US and EU
  • Experience in seeking clinical trial or marketing authorization for markets including US, EU, AU, Japan, and emerging markets eg BRIC
  • Working knowledge of Software as a Medical Device (SaMD) and related regulatory strategies
  • Prior experience as Lead on development teams (devices and therapeutics).

REF: 862

 

  • Contract Type:

    Contract opportunity

  • Location:

    Flexible; US based

  • Duration:

    12 months+

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