Regulatory Engineer

About the Company

Neuralink is creating devices that enable a bi-directional interface with the brain to restore movement to the paralyzed, restore sight to the blind, and revolutionize human-digital interaction.

Responsibilities

• Manage regulatory affairs activities and interactions with international regulatory bodies during clinical evaluations and market introduction
• Develop regulatory approaches for devices under development and prepare pre-market regulatory submissions
• Partner with R&D, hardware, software, and preclinical teams to integrate regulatory requirements into product architecture
• Evaluate device classification, risk profiles, and global approval pathways
• Prepare high-quality regulatory submissions including IDE, PMA, and international dossiers
• Assess design, manufacturing, and clinical changes for regulatory impact
• Build internal tools, SOPs, and processes to streamline compliance
• Stay current on global standards and translate them into actionable guidance for engineering teams

Requirements

• Bachelor’s Degree or higher in an applicable engineering discipline (biomedical, mechanical, manufacturing, electrical, software, etc.)
• Strong technical writing and communication skills
• Excellent collaboration and organizational skills

Preferred Qualifications

• 1+ years of experience in regulatory submissions or quality engineering for medical devices
• Hands-on background in medical device design, testing, or risk management (ISO 14971)
• Experience with class II/III medical device design and manufacturing