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Regulatory Affairs Specialist
Regulatory Affairs SpecialistKatalyst Healthcares & Life Sciences • Irvine, CA, US
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Katalyst Healthcares & Life Sciences • Irvine, CA, US
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Regulatory Affairs Specialist Ii

Regulatory affairs specialist ii with working knowledge of fda, and ce marking requirements for ivd products. Client is currently transitioning from ivdd to ivdr (in vitro diagnostic regulation). The ras is responsible for preparation & revision of ivd technical files when needed, updating labeling to comply with ivdr requirements, and tracking ra regional notifications res...

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Regulatory Specialist • Irvine, CA, US

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