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Regulatory Affairs Consultant - Irvine, United States - Redbock - an NES Fircroft company
Description
A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of aRegulatory Affairs Consultant
to support them for
approximately 3 months . The consultant will need to work
onsite at least 3 days/week .
The Regulatory Affairs Consultant will be focused on the hands-on development of a
Special 510k
regulatory submission with a deadline of early July 2024.
The Regulatory team is currently only 3 people so this consultant will need to work mostly independently to create the 510k submission.
This consultant may also be involved in the review of test protocols in coordination with the R&D and Quality teams.
Top Requirements:
BS degree minimum
5+ years of Medical Device industry experience as a Regulatory Affairs specialist
Orthopedics device experience is a plus
Experience with devices that have software components is a plus
Able to independently develop a 510k submission, requires strong knowledge of all components/sections that go into this submission
Experience with Special or Abbreviated 510k submissions is a plus
Strong communication skills, able to collaborate effectively with cross-functional teams
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