Regulatory Engineer

Job description

**About Neuralink:** 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. **Team Description:** 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. **Job Description and Responsibilities:** 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: - 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 (IDE, PMA, international equivalents, supplements, dossiers, etc.) 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. - Contribute to cross-functional problem-solving on topics ranging from biocompatibility and electromagnetic compatibility to software validation and human factors. **Required 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. **Preferred Qualifications:** - 1+ years of experience in regulatory submissions, technical documentation, or quality engineering for medical devices (IDE, PMA, 510(k), international filings, etc.). - Hands-on background in medical device design, testing, risk management (ISO 14971), or preclinical/clinical studies. - Experience with class III/II medical device design, manufacturing, testing, and/or regulatory processes. **Expected Compensation:** 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. Base Salary Range: $71,000—$119,000 USD **What We Offer:** Full-time employees are eligible for the following benefits listed below. - An opportunity to change the world and work with some of the smartest and most talented experts from different fields - Growth potential; we rapidly advance team members who have an outsized impact - Excellent medical, dental, and vision insurance through a PPO plan - Paid holidays - Commuter benefits - Meals provided - Equity (RSUs) *\*Temporary Employees & Interns excluded* - 401(k) plan *\*Interns initially excluded until they work 1,000 hours* - Parental leave *\*Temporary Employees & Interns excluded* - Flexible time off *\*Temporary Employees & Interns excluded*