Hiring: Regulatory Engineer Company: Neuralink Location: Austin, TX Job Posted Time: 2026-09-10 10:34:28 Employment Type: Full-time Target Skills & Keywords : R, Regulatory Compliance About the job Experience: •1+ years of experience in regulatory submissions, technical documentation, or quality engineering for medical devices (IDE, PMA, 510(k), international filings, etc.). Required Skills: •Join the Regulatory Team, where our mission is to enable global access to Neuralink’s technology. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for maintaining the pace of innovation within highly regulated environments. •Partner directly with R&D, hardware, software, and preclinical teams to integrate regulatory requirements into product architecture, testing strategies, and development roadmaps. •Evaluate device classification, risk profiles, and global approval pathways, then design efficient technical solutions and documentation strategies that accelerate timelines. •Identify regulatory and compliance obstacles early, anticipate emerging issues, and propose creative, data-driven workarounds, design refinements, or filing strategies that maintain innovation speed. •Prepare high-quality regulatory submissions by organizing technical evidence, preclinical data, clinical results, and other materials into clear, compelling packages. •Assess proposed design, manufacturing, preclinical, clinical, and testing changes for regulatory impact and develop appropriate filing strategies. •Build and improve internal tools, templates, SOPs, and processes that make regulatory compliance faster and less burdensome for engineering teams; provide training to stakeholders to ensure organization-wide compliance. •Stay technically current on evolving global standards, translate them into actionable guidance for designers, test engineers, and clinical teams, and distribute updated regulatory intelligence across the organization. Qualifications: •Bachelor’s Degree or higher in an applicable engineering discipline (e.g., biomedical, mechanical, manufacturing, electrical, software, etc.) •Strong technical writing and communication skills — ability to explain complex engineering concepts clearly and concisely. •Excellent collaboration and organizational skills; comfort working in a fast-moving, cross-functional environment. •Hands-on background in medical device design, testing, risk management (ISO 14971), or preclinical/clinical studies. •Base Salary Range:: $71,000 USD - $119,000 USD Compensation: •Excellent medical, dental, and vision insurance through a PPO plan Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!