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Strategic IVDR Regulatory Affairs Senior Manager

Job in Boston, Suffolk County, Massachusetts, 02298, USA
Listing for: Sophia Genetics SA
Full Time position
Listed on 2025-12-02
Job specializations:
  • Management
    Healthcare Management
  • Healthcare
    Healthcare Management, Healthcare Administration
Job Description & How to Apply Below
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.
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Position Requirements
10+ Years work experience
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