Regulatory Affairs Professional 2
Location: Issaquah
Posted on: June 23, 2025
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Job Description:
Job Summary: We are seeking a Regulatory Affairs Specialist
(Contractor) with expertise in China NMPA registration for
ultrasound imaging devices. The role involves supporting the
preparation and compilation of regulatory submissions to ensure
timely product approvals in China. The ideal candidate is
detail-oriented, independent, and experienced in a fast-paced,
cross-functional environment.\n\nResponsibilities:\nPrepare and
compile regulatory submission documents for ultrasound imaging
devices per China NMPA requirements^Coordinate with internal teams
including RA, R&D, Clinical, and Marketing to gather technical
and compliance documentation^Ensure accuracy and completeness of
technical files and Clinical Evaluation Reports (CERs) according to
Chinese regulatory standards^Track submission timelines and support
communication with local agents or legal representatives if
applicable^Maintain organized records of documentation and
submission status to support audits and inquiries
Keywords: , Everett , Regulatory Affairs Professional 2, Science, Research & Development , Issaquah, Washington
