{"id":235431,"url":"https://alion.io/job/neuralink-regulatory-engineer","title":"Regulatory Engineer","company":{"id":8,"name":"Neuralink","domain":"neuralink.com","url":"https://alion.io/company/neuralink","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":74,"open_postings":77,"ghost_share":0.351,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":138,"computed_at":"2026-10-26T05:57:25Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Austin, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":71000,"max":119000,"currency":"USD","period":"year","gross":null,"usd_annual":119000},"salary_estimate":null,"experience_years_min":1,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"ISO 10993","optional":false},{"name":"FDA 510(k)","optional":true},{"name":"ISO 14971","optional":true}],"status":"live","first_seen_at":"2026-05-20T16:13:25Z","employer_posted_date":"2026-09-25","last_verified_at":"2026-10-27T05:18:17Z","board_verified":true,"closed_at":null,"days_open":159,"trust":{"level":"ok","repost_count":0,"flags":["company_stale"],"days_open":159},"description":"About Neuralink:\nWe 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.\nTeam Description:\nJoin 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.\nJob Description and Responsibilities:\nAs 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:\nPartner directly with R&D, hardware, software, and preclinical teams to integrate regulatory requirements into product architecture, testing strategies, and development roadmaps.\nEvaluate device classification, risk profiles, and global approval pathways, then design efficient technical solutions and documentation strategies that accelerate timelines.\nIdentify regulatory and compliance obstacles early, anticipate emerging issues, and propose creative, data-driven workarounds, design refinements, or filing strategies that maintain innovation speed.\nPrepare 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.\nAssess proposed design, manufacturing, preclinical, clinical, and testing changes for regulatory impact and develop appropriate filing strategies.\nBuild 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.\nStay 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.\nContribute to cross-functional problem-solving on topics ranging from biocompatibility and electromagnetic compatibility to software validation and human factors.\nRequired Qualifications: \n\nBachelor’s Degree or higher in an applicable engineering discipline (e.g., biomedical, mechanical, manufacturing, electrical, software, etc.)\nStrong technical writing and communication skills - ability to explain complex engineering concepts clearly and concisely.\nExcellent collaboration and organizational skills; comfort working in a fast-moving, cross-functional environment.\nPreferred Qualifications: \n\n1+ years of experience in regulatory submissions, technical documentation, or quality engineering for medical devices (IDE, PMA, 510(k), international filings, etc.).\nHands-on background in medical device design, testing, risk management (ISO 14971), or preclinical/clinical studies.\nExperience with class III/II medical device design, manufacturing, testing, and/or regulatory processes.\nExpected Compensation:\nThe 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.\nBase Salary Range:\n$71,000—$119,000 USD\nWhat We Offer:\nFull-time employees are eligible for the following benefits listed below.\nAn opportunity to change the world and work with some of the smartest and most talented experts from different fields\nGrowth potential; we rapidly advance team members who have an outsized impact\nExcellent medical, dental, and vision insurance through a PPO plan\nPaid holidays\nCommuter benefits\nMeals provided\nEquity (RSUs) *Temporary Employees & Interns excluded\n401(k) plan *Interns initially excluded until they work 1,000 hours\nParental leave *Temporary Employees & Interns excluded\nFlexible time off *Temporary Employees & Interns excluded","description_format":"text","description_chars":4581,"description_truncated":false,"requirements":{"experience_years_min":1,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Flexible time off","Parental leave","Restricted stock units","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Medical & Healthcare Robotics","Neurotech & Neuromodulation"],"lifecycle":[{"event":"open","at":"2026-09-05T10:03:10Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 25 · green card filings: 1","filings_12m":25,"filings_prev_12m":12,"green_card_filings_12m":1,"median_offered_wage_usd":145962,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":19,"band":"cold","label":"Long shot","p_open":0.6,"p_active":0.73,"p_room":0.44,"age_days":158,"expected_fill_days":138,"reasons":["seen:31","velocity","win:tail","crowd:junior"],"computed_at":"2026-10-26T05:57:25Z"},"pay":{"stated_usd_annual":119000,"is_top_pay":true},"html_url":"https://alion.io/job/neuralink-regulatory-engineer","json_url":"https://alion.io/job/neuralink-regulatory-engineer.json","meta":{"generated_at":"2026-10-27T05:19:30Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":5083,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":8},"rest":"https://alion.io/mcp/rest/get_company?id=8"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fneuralink-regulatory-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fneuralink-regulatory-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fneuralink-regulatory-engineer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/neuralink-regulatory-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fneuralink-regulatory-engineer"}]}