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Regulatory Affairs Professional 2

Location: Issaquah
Posted on: June 23, 2025

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: , Federal Way , Regulatory Affairs Professional 2, Science, Research & Development , Issaquah, Washington


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