Regulatory Affairs Consultant - IVD/ Software

Regulatory Affairs Consultant - China (IVD / IUO / Software) Location: U.S.-based (remote) Engagement: Contract / Consulting (scope and duration TBD) Overview We are supporting a U.S.-based life sciences company exploring current and future regulatory needs related to China-specific regulatory requirements for IVD / IUO products , including software-driven systems . This is a consulting opportunity for an experienced Regulatory Affairs professional with demonstrated expertise navigating Chinese regulatory pathways , particularly for diagnostics and software. The engagement is expected to be advisory and/or hands-on , depending on program needs, and may evolve as development plans progress. Key Responsibilities Provide regulatory guidance related to China (NMPA) requirements for IVD, IUO, and software-enabled products Advise on regulatory strategy to ensure alignment during product development with future China market considerations Support interpretation and application of China-specific regulations , standards, and guidance documents Review and assess software lifecycle documentation and regulatory readiness Partner cross-functionally with Clinical, R&D, Quality, and Engineering stakeholders Identify regulatory risks and recommend mitigation strategies early in development Support planning for potential future NMPA submissions , as applicable Required Experience & Qualifications 7+ years of Regulatory Affairs experience within medical devices, diagnostics, or software-driven products Direct experience with China regulatory frameworks (NMPA), particularly for IVDs or related technologies Strong understanding of IUO / RUO vs. clinical/commercial regulatory pathways Experience supporting software as part of a diagnostic system (standalone or embedded) Ability to operate independently in a consultative capacity Bachelor's degree in a scientific, engineering, or related discipline (advanced degree a plus)

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