Neuralink · 5 hours ago
Regulatory Affairs Specialist
Austin, TX
Full-time
Onsite
Entry, Mid Level
$71K/yr - $119K/yr
2+ years expNeuralink is creating devices that enable a bi-directional interface with the brain, aiming to restore movement and sight. The Regulatory Affairs Specialist will manage regulatory activities and ensure compliance with standards throughout the product lifecycle, including pre-market submissions and post-approval reporting.
BiotechnologyMedicalNeuroscienceRobotics
Responsibilities
Evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing) to ensure product compliance
Identify regulatory obstacles, anticipate emerging issues, and propose solutions or refinements based on regulatory outcomes
Evaluate product classification and determine regulatory submission requirements, approval pathways, and compliance options, as well as prepare regulatory filings in line with applicable guidelines
Develop and implement new regulatory procedures and SOPs, and provide training to stakeholders to ensure organization-wide compliance
Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans or strategize for changes that do not require submissions
Maintain proficiency in worldwide regulatory requirements and distribute updated information regarding worldwide laws, guidelines, and standards
Collect, organize, and maintain files on local, regional, and global regulatory intelligence and other related information
Provide information used to evaluate proposed products for regulatory classification and jurisdiction
Organize materials from preclinical and clinical studies for review and assist in the review process
Compile and organize materials for pre-submission reports and communications
Assist in the preparation of dossiers, pre-submission, and submission packages for regulatory agencies
Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders
Qualification
Required
Bachelor's Degree or higher in an applicable science or engineering discipline
2+ years of professional experience in regulatory submissions and technical documentation (e.g., IDE, HDE, PMA, notices, supplements, routine reports)
Excellent communication, collaboration, and organization skills
Preferred
Experience with significant risk medical device-related regulatory filings
Experience with robotics, software, and cybersecurity-related regulatory filings
RAPs or ASQ certification or other scientific/technical training
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) 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
Company
Neuralink
Neuralink is a neurotechnology company that focuses on developing brain-computer interfaces designed to treat neurological disorders.
201-500 employees
Funding
Current Stage
Late StageTotal Funding
$1.34BKey Investors
CoreNest CapitalFounders FundVy Capital
2025-07-07Series Unknown
2025-06-17Secondary Market
2025-05-27Series E· $649M
Leadership Team
Dongjin Seo
Co-Founder, President & COO
Shivon Zilis
Director of Operations and Special Projects
Recent News
2026-01-09
Company data provided by crunchbase