Regulatory Engineer

Neuralink; Austin (TX); On-site; USD 71,000 - 119,000; Full time

Benefits offered by this job

Excellent medical, dental, and vision insurance

Paid holidays

Meals provided

Equity compensation (RSUs)

401(k) plan

Parental leave

Flexible time off

Job summary

Neuralink is looking for a Regulatory Engineer in Austin, Texas, to join their Regulatory Team. This role involves managing regulatory affairs and ensuring compliance during product development and post-market phases. Candidates should have a Bachelor’s degree in engineering and strong communication skills.

The anticipated salary range for this position is between $71,000 and $119,000, with equity compensation available to full-time employees.

Qualifications

• 1+ years of experience in regulatory submissions or quality engineering for medical devices.
• Hands-on background in medical device design or testing.
• Experience with class III/II medical devices.

Responsibilities

• Responsible for regulatory affairs activities and interactions with regulatory bodies.
• Prepare high-quality regulatory submissions and assess design changes for regulatory impact.
• Build and improve internal tools and processes for regulatory compliance.

Skills

Technical writing

Communication skills

Collaboration skills

Organizational skills

Education

Bachelor’s Degree in applicable engineering discipline

Job description

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 USD - $119,000 USD

Benefits

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
• 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