Regulatory Affairs Specialist Jobs in Irvine
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Search Results - Regulatory Affairs Specialist Jobs in Irvine
Katalyst Healthcares & Life Sciences-Irvine
Responsibilities:
Complete and maintains regulatory approvals/clearances of heart valve replacement and repair devices,
Represent the Regulatory function on manufacturing and product development teams to provide input on regulatory requirements...
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Katalyst Healthcares & Life Sciences-Irvine
agencies (Primarily US FDA).
Assess the appropriate regulatory reporting mechanism using FDA regulations, guidance documents, and in-house policies upon review of Change Control Documentation.
Work closely with Regulatory Affairs, Quality Assurance...
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Katalyst Healthcares & Life Sciences-Irvine
Responsibilities:
Reviews product labelling for accuracy and for other legal/regulatory requirements and communicates planned/approved changes with other functions, including but not limited to operations, medical affairs and commercial teams...
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Katalyst Healthcares & Life Sciences-Irvine
Responsibilities:
Must Have MDR experience. IVD (In-vitro Diagnostics) is highly preferred.
Support the IVDR project by revising the assigned technical files. Each technical file must be generated using the latest technical file template and it...
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Katalyst Healthcares & Life Sciences-Irvine
and written communication skills.
Thorough knowledge of policies, practices and procedures related to Regulatory Affairs....
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