Consultant US FDA Submissions (m/f/d) Freelance

Reference number: 1234

We are looking for a freelance consultant for our client for the following project:

Task:

  • US submission: 510(k) or PMA depending on feasibility
  • Product: HF Surgery and irrigation pumps, class 2a/b
  • Compiling and reviewing necessary documentation for US registration
  • Communication with FDA and if possible acting as FDA agent

Necessary Experience:

  • Expert for Regulatory Affairs / Medical Devices
  • Expert with US 510(k) or PMA Submissions
  • Extensive expertise regarding active medical devices
  • Experience with FDA related procedures

Frame:

  • Start: ASAP
  • Duration: 12 Months
  • Workload requirement: approximately 25-30 hours per week
  • Location: Remote, however, needs to be based in the US

Interested? Get in touch with Ana Aleksova

aleksova@arcoro.de or +4915115623724

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