Job Details

  • Title: Regulatory Affairs Project Leader
  • Code: RCI-11374
  • Location: Atlanta Georgia (GA) 30313
  • Posted Date: 02/23/2021
  • Duration: 9 Months
Talk to our Recruiter

  Job Description

Position can be remote (east coast preferred) or onsite in Atlanta, GA.

  • Degree in engineering or scientific background
  • Minimum of 3-5 years of Regulatory Affairs submission authoring experience in Class III Active Implantable Medical Devices or Class II Medical Devices
  • Experience with EU MDR (Medical Device Regulations) highly preferred; not to be confused with MDR Vigilance Reporting experience (Regulatory Compliance), which is not applicable.
  • Other critical soft skills: Excellent communication verbal and written skills
  • Ability to lead independently with strong critical analysis skills
  • This contract position is for the EU MDR submission project and will dependent on when the EU MDR submission will be finished.
  • Need someone onboard quickly, will interview ASAP. Need start up mentality - must be able to fill in gaps for MDR and submissions writing.