Posted 2 months ago

Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)

San DiegoOn-siteFull-time

AI Summary

Leads regulatory strategy and submissions for medical diagnostics in the US market; coordinates with FDA and global agencies and supports product launches.

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Title: Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking) - CorDx

URL Source: https://apply.workable.com/j/884F46D64C

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Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking) - CorDx

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Skills

Clinical Trial DocumentationCMC DocumentationCOO/CMC SubmissionCross-Functional CollaborationDMF ManagementDocumentation ControlEUA/expedited PathwaysFDA/FD&C ComplianceICH GuidelinesLabeling And Packaging ComplianceMedical Device RegulationsNon-clinical/CMC SubmissionsQuality AuditsQuality SystemsRegulatory AffairsRegulatory SignalingRegulatory StrategyRisk AssessmentUS FDA 510(k) Pathway

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