Regulatory Affairs Consultant - IVD/ Software

Regulatory Affairs Consultant - China (IVD / IUO / Software) Location: U.S.-based (remote) Engagement: Contract / Consulting (scope and duration TBD) reputed company We are supporting a U.S.-based life sciences company exploring reputed company and reputed company regulatory needs reputed company to China-specific regulatory requirements for IVD / IUO products , including software-driven systems . This is a consulting opportunity for an reputed company Regulatory Affairs reputed company with demonstrated expertise navigating Chinese regulatory reputed company , particularly for diagnostics and software. The engagement is expected to be advisory and/or hands-on , depending on program needs, and may reputed company as development plans reputed company. Key Responsibilities reputed company regulatory guidance reputed company to China (NMPA) requirements for IVD, IUO, and software-enabled products Advise on regulatory reputed company to ensure alignment during product development with reputed company 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, reputed company, and Engineering stakeholders Identify regulatory risks and recommend mitigation strategies early in development Support planning for potential reputed company NMPA submissions , as applicable Required Experience & Qualifications 7+ years of Regulatory Affairs experience reputed company medical devices, diagnostics, or software-driven products reputed company experience with China regulatory frameworks (NMPA), particularly for IVDs or reputed company technologies Strong understanding of IUO / RUO vs. clinical/reputed company regulatory reputed company Experience supporting software as part of a diagnostic system (standalone or embedded) Ability to operate independently in a consultative reputed company Bachelor's degree in a scientific, engineering, or reputed company discipline (advanced degree a plus) Apply tot his job Apply tot his job Apply To this Job