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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