Regulatory Affairs Specialist (NMPA)
Core
Partner with in-country RA and Product Localization Engineering teams to ensure regulatory compliance with China requirements throughout the product lifecycle, managing filings, licenses, and pre/post-market activities.
Role type
Regulatory Affairs Specialist (NMPA)
Builds
Regulatory submissions and compliance for medical devices in the China market
Domain
Medical Devices / Regulatory Affairs / China Market
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
NMPA medical device regulatory requirements, China GB/YY standards, US FDA fundamentals, project management, regulatory strategy development, dossier writing and review, stakeholder coordination, audit support, localization project support
Preferred skills
SaMD and SiMD knowledge, RIMS systems (Veeva, Rimsys), RAC certification, SAP, Agile methodologies
Technologies
Microsoft Word, Excel, Project, Veeva, Rimsys, SAP
Responsibilities
Act as RA project lead for China product registration applications; Coordinate regulatory/clinical strategy development and timeline establishment; Provide explanations of China regulatory requirements to support teams; Coordinate and prioritize tasks with oversight; Support Product Technical Requirement (PTR) draft and type testing; Write and review sections of the registration dossier; Create and maintain registration trackers; Maintain China Regulatory Project Executive Summary; Review and approve GRAs; Articulate local regulatory requirements and assist in developing internal procedures; Support internal and external audits; Provide working-level guidance to contractors
Seniority
Mid-level, hands-on IC with project lead responsibilities
