Regulatory Engineer
Core
Enable global access to Neuralink's brain-computer interface technology by managing regulatory affairs, clinical evaluations, and market introduction for medical devices.
Role type
Regulatory Engineer (Medical Devices)
Builds
Regulatory submissions (IDE, PMA, 510(k)), technical documentation, and compliance strategies for neural interface devices.
Domain
Medical device regulation / Biomedical engineering
Deliverable
client delivery
Required skills
Regulatory submissions, technical writing, risk management (ISO 14971), device classification, global approval pathways, compliance reporting, SOP development, cross-functional collaboration
Preferred skills
Medical device design, preclinical/clinical studies, class III/II device processes, quality engineering
Technologies
IDE, PMA, 510(k), ISO 14971
Responsibilities
Interact with international regulatory bodies during clinical evaluations and market introduction; develop regulatory approaches for devices under development; prepare pre-market regulatory submissions and post-approval reports; partner with R&D and engineering teams to integrate regulatory requirements into product architecture; evaluate device classification and risk profiles; build internal tools and processes for regulatory compliance.
Seniority
Individual Contributor