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Regulatory Affairs Specialist

  • Date Posted September 9, 2020
  • Location Danvers, MA
  • Job Type Contract
  • Job ID 16237

Regulatory Affairs Specialist

Our Medical Device client is one of the fastest growing in the world and global leader in healthcare technology witha mission of saving lives. They are looking for a key person to work a 6 month regulatory affairs specialist role as a contractor.

Key Responsibilities:

  • Prepare and review FDA submissions and other regulatory documents including 510(k)s, IDEs, Qsubs, PMA Supplements, PMA Amendments, and PMA Annual Reports
  • Actively participate on project teams
  • Review relevant guidance documents and provide interpretative assistance for new filings Review and edit technical reports for incorporation into regulatory submissions
  • Communicate regulatory plans and project status to internal stakeholders

QUALIFICATIONS

  • Degree in engineering or science required, advanced degree is preferred
  • Minimum of 5 years of regulatory affairs experience in the medical device industry with a track record of successful submissions. Class III medical device experience is preferred.
  • Must have excellent communication and organizational skills. Must have effective regulatory writing skills
  • Must be able to execute tasks in a timely manner with minimal supervision Must be able to prioritize tasks
  • Must be able to work remotely effectively
  • Must be proficient in Microsoft Office Suite, including MS Teams

Please contact Earl at ecallender@daleyaa.com for consideration.

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