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)