Regulatory Affairs Specialist

About Neuralink:

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.

Team Description:

Join the Quality Team, where our mission is to ensure compliance with relevant regulatory standards. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance.

Job Description and Responsibilities:

As the Regulatory Affairs Specialist 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:

• 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

Required Qualifications:

• 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 Qualifications:

• 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

Expected Compensation:

At Neuralink, your base pay is one part of your total compensation package. The anticipated base salary for this position is expected to be within the below range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training.

What We Offer:

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
• Commuter benefits
• Meals provided
• Equity + 401(k) plan *Temporary Employees & Interns excluded
• Parental leave *Temporary Employees & Interns excluded
• Flexible time off *Temporary Employees & Interns excluded