Regulatory Affairs Consultant (LS-220221)
Start Date: April 2017
Location: Northeast
Duration: 9-12 months
Pay Rate: DOE
Type: Contract
Job Description

Client is in need of a senior level consultant with significant regulatory affairs related experience to help prepare submissions and related documentation 



Skills

The client is preparing their next generation Class III Cardiovascular device to submit a design dossier for:

  • CE Mark
  • Clinical study
  • First-in human study
  • Regulatory documentation preparation for their PMA submission and Japanese submission


Experience
  • 10+ years of Regulatory Affairs experience
  • Cardiovascular device product experience
  • PMA experience for US, CE Mark/Design Dossier for EU and Japanese submission experience is a plus (would accept candidate without, but in the long-term the client will be submitting the device to Japan as well. Without this experience, it may shorten the assignment)
  • Must have experience interacting with notified bodies for submissions

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