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Sophia Genetics SA

Strategic IVDR Regulatory Affairs Senior Manager

Sophia Genetics SA, Boston, Massachusetts, us, 02298

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A biotechnology company is seeking a IVDR Regulatory Affairs Manager/Senior Manager in Boston, MA. This role involves managing IVDR strategy and submission efforts to ensure timely product approvals. The ideal candidate will have significant experience in Regulatory Affairs within Diagnostics, particularly regarding IVDR Class C submissions. Knowledge of oncology regulatory frameworks is a plus. The position offers a hybrid work schedule with comprehensive benefits. #J-18808-Ljbffr