Regulatory Engineer

<div class="content-intro"><p><strong>About Neuralink:</strong></p>

<p>We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.</p></div><p><strong>Team Description:</strong></p>

<p>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.</p>

<p><strong>Job Description and Responsibilities:</strong></p>

<p>As a Regulatory Engineer at Neuralink, you will be responsible for regulatory affairs activities and interactions with international regulatory bodies during clinical evaluations and/or market introduction, as well as compliance and reporting activities in the post-market phase. Additionally, you will develop regulatory approaches for devices under development, prepare pre-market regulatory submissions, and create post-approval reports. Furthermore, you will be expected to:</p>

<ul>

<li>Partner directly with R&D, hardware, software, and preclinical teams to integrate regulatory requirements into product architecture, testing strategies, and development roadmaps.</li>

<li>Evaluate device classification, risk profiles, and global approval pathways, then design efficient technical solutions and documentation strategies that accelerate timelines.</li>

<li>Identify regulatory and compliance obstacles early, anticipate emerging issues, and propose creative, data-driven workarounds, design refinements, or filing strategies that maintain innovation speed.</li>

<li>Prepare high-quality regulatory submissions (IDE, PMA, international equivalents, supplements, dossiers, etc.) by organizing technical evidence, preclinical data, clinical results, and other materials into clear, compelling packages.</li>

<li>Assess proposed design, manufacturing, preclinical, clinical, and testing changes for regulatory impact and develop appropriate filing strategies.</li>

<li>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.</li>

<li>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.</li>

<li>Contribute to cross-functional problem-solving on topics ranging from biocompatibility and electromagnetic compatibility to software validation and human factors.</li>

</ul>

<p><strong>Required Qualifications: </strong><strong><br></strong></p>

<ul>

<li>Bachelor’s Degree or higher in an applicable engineering discipline (e.g., biomedical, mechanical, manufacturing, electrical, software, etc.)</li>

<li>Strong technical writing and communication skills — ability to explain complex engineering concepts clearly and concisely.</li>

<li>Excellent collaboration and organizational skills; comfort working in a fast-moving, cross-functional environment.</li>

</ul>

<p><strong>Preferred Qualifications:</strong><strong> </strong><strong><br></strong></p>

<ul>

<li>1+ years of experience in regulatory submissions, technical documentation, or quality engineering for medical devices (IDE, PMA, 510(k), international filings, etc.).</li>

<li>Hands-on background in medical device design, testing, risk management (ISO 14971), or preclinical/clinical studies.</li>

<li>Experience with class III/II medical device design, manufacturing, testing, and/or regulatory processes.</li>

</ul><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p><strong>Expected Compensation:</strong></p>

<p>The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees’ success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.</p></div><div class="title">Base Salary Range:</div><div class="pay-range"><span>$71,000</span><span class="divider">—</span><span>$119,000 USD</span></div></div></div><div class="content-conclusion"><div>

<p><strong>What We Offer:</strong></p>

<p>Full-time employees are eligible for the following benefits listed below.</p>

<ul>

<li>An opportunity to change the world and work with some of the smartest and most talented experts from different fields</li>

<li>Growth potential; we rapidly advance team members who have an outsized impact</li>

<li>Excellent medical, dental, and vision insurance through a PPO plan</li>

<li>Paid holidays</li>

<li>Commuter benefits</li>

<li>Meals provided</li>

<li>Equity (RSUs) <em>*Temporary Employees & Interns excluded</em></li>

<li>401(k) plan <em>*Interns initially excluded until they work 1,000 hours</em></li>

<li>Parental leave <em>*Temporary Employees & Interns excluded</em></li>

<li>Flexible time off <em>*Temporary Employees & Interns excluded</em></li>

</ul>

</div></div>