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Regulatory Engineer

Neuralink· Translational
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Austin, TX$71k - $119kFull-timePosted 5mo ago

About the role

Regulatory Engineer responsible for regulatory affairs activities across clinical evaluations, market introduction, and post-market compliance; partner with cross-functional teams to integrate regulatory requirements into product development and ensure global regulatory approvals.

Responsibilities

  • 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.

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.

Skills

Required:Regulatory submissionsTechnical writingCross-functional collaboration

Benefits

  • 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)
  • 401(k) plan
  • Parental leave
  • Flexible time off
Last updated Jul 8, 2026. Interested? Apply on the company site.

About Neuralink

Pioneering Brain Computer Interfaces

Creating a generalized brain interface to restore autonomy to those with unmet medical needs today and unlock human potential tomorrow.

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