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Regulatory Affairs Specialist

Company name
Cepheid, A Subsidiary Of Danaher Corporation

Mountain View, CA

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REGULATORY Cepheid, a subsidiary of Danaher Corporation, is a leader in molecular diagnostic testing. We have the following position available at our offices in Sunnyvale, CA: Regulatory Affairs Specialist - to prepare the regulatory submissions and interacting with regulatory agencies and health authorities to obtain and maintain product approvals with a focus on China and Taiwan.


Master's degree or foreign equivalent in Chemistry, Biology, Microbiology, Medical Technology or related field and three (3) years of experience ensuring compliance by communicating regulatory requirements in the life science, healthcare, or diagnostics industry; interpreting and applying ISO guidelines (ISO13485 and ISO 9001) and standards, US FDA 21 CFR Part 820 - Quality System Regulation, and ICH Q7 guidelines; managing change controls and risk mitigation activities; interpreting and compiling in cGMP/Quality Systems requirements; preparing, generating and approving Non-Conformance/CAPA Reports; and preparing internal audits and responding to external audits. Alternatively, a Bachelor's degree and five (5) years of progressive experience as stated above. Fluency in written simplified and traditional Chinese and spoken Mandarin required. Approximately 10% -20% travel required. Interested candidates should email resumes -- with reference to the job title -- to (please use the apply button below).recblid 88p1mcjq1neo2r3pvojadyqxm695w9

Company info

Cepheid, A Subsidiary Of Danaher Corporation

Company Profile

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