Neuralink

Neuralink

Regulatory Engineer

Austin, Texas, United States · Junior · Contract

Sponsorship not specified$71k-$119kDetected 27 days ago
ComplianceEMI/EMCFDA RegulatoryMedical DevicesAnimal StudiesCommunicationCollaborationProblem SolvingWritingOrganizational SkillsRegulatory Affairs

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odds of building a lasting career here

50Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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Employer immigration record

from this employer's Department of Labor filings

Green-card filing pattern in this occupation

Context, not a finding about this posting: of this employer's 3 green-card filings in this occupation, 100% were for a worker who already held the job.

Files H-1B transfers

5 transfer filings in the last year, covering 5 workers. Median labor-condition decision: 10 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • 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.
  • 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.

Responsibilities

  • Additionally, you will develop regulatory approaches for devices under development, prepare pre-market regulatory submissions, and create post-approval reports.
  • 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.
  • 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.

Requirements

  • 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.
  • comfort working in a fast-moving, cross-functional environment.

Nice to have

  • Expected Compensation:
  • We also believe in aligning our employees' success with the company's long-term growth.
  • 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

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.
  • As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.
  • $71,000 - $119,000 USD

Benefits

  • Full-time employees are eligible for the following benefits listed below.
  • Excellent medical, dental, and vision insurance through a PPO plan
  • Commuter benefits
  • Equity (RSUs) *Temporary Employees & Interns excluded
  • Parental leave *Temporary Employees & Interns excluded
  • Flexible time off *Temporary Employees & Interns excluded

Company info

  • 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.
  • 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.

This listing is sourced directly from Neuralink's careers page and normalized into a canonical job model.