Open Roles
This Regulatory Affairs Specialist position serves as a critical bridge between Intuitive's in-country Regulatory Affairs team and Product Localization Engineering teams. The role ensures all regulatory affairs activities are conducted in accordance with company policies and comply with the latest China regulatory requirements and standards.
You will act as the RA project lead for China product registration applications, serving dual roles as both the RA Lead and RA Project Manager. This includes coordinating regulatory and clinical strategy development, establishing timelines, and providing explanations to ISI supportive teams on China regulatory requirements through collaboration with JVRA partners.
You will coordinate and prioritize tasks with oversight, support activities related to Product Technical Requirement (PTR) drafting and type testing, including test sample arrangement. The role requires maintaining regulatory filings and licenses while providing support to cross-functional teams for pre-market applications and post-market regulatory compliance matters.
The ideal candidate will have strong project management capabilities, deep understanding of NMPA submission requirements, and excellent cross-functional collaboration skills. Experience with medical device regulatory affairs, particularly in the China market, is essential for success in this role.