Senior Regulatory Affairs Specialist

2 months ago


massachusetts, United States Lumicity Full time

A client of ours is looking to bring on a Senior Regulatory Affairs Specialist to work on cutting edge Class II and Class III medical devices.


Essential Requirements

  • 4+ years of Regulatory Affairs Experience in the Medical Device space
  • Experience as lead author on a major FDA submission (510k or PMA preferred)
  • B.S in Biology, Chemistry, Biomedical Engineering or a similar field
  • U.S Ad/Promo experience
  • International regulatory experience (LATAM, EU, APAC, Health Canada)
  • Preference given to candidates based in Massachusetts, but candidates can be based anywhere in the United States, this role is remote


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