- 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
- Strong communication skills, able to collaborate effectively with cross-functional teams
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Regulatory Affairs Consultant
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Redbock - an NES Fircroft company Irvine, United StatesA fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a · Regulatory 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 ...
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Regulatory Affairs Consultant
3 weeks ago
Redbock - an NES Fircroft company Irvine, United StatesRegulatory Affairs Consultant · Irvine, CA · A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a · Regulatory Affairs Consultant · to support them for · approximately 3 months . The consultant will need to work · onsite at least 3 days/wee ...
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Specialist, Site Communications
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Group Brand Manager, Critical Care
1 week ago
Edwards Lifesciences Irvine, United StatesJob Description · For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we're committed to creating a world where every pa ...
Regulatory Affairs Consultant - Irvine, United States - Redbock - an NES Fircroft company
Description
Regulatory Affairs Consultant
Irvine, CA
A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a Regulatory 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:
