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AccuScan Sciences

EU IVDR Regulatory Lead for Oncology Molecular Diagnostics

milpitas, CA

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About this opportunity

AccuScan Sciences lists this EU IVDR Regulatory Lead for Oncology Molecular Diagnostics opportunity in milpitas, California. Review the employer’s description below for duties, qualifications and application requirements.

Job description

AccuScanSciences is seeking an experienced CE-IVDR Regulatory Consultant to lead and support European regulatory strategy for our oncology molecular diagnostics portfolio, including tumor-informed MRD assays.

The role provides strategic and hands-on regulatory expertise to support CE-IVDR compliance, technical documentation, performance evaluation strategies, Notified Body interactions, and cross-functional collaboration with product development, quality, manufacturing, and external CDMO

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Worksite address

milpitas, CA, 95035, US

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