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