Neuralink
About Neuralink
We are creating devices that enable a bi‑directional interface with the brain, allowing the paralyzed to regain movement, the blind to regain sight, and people to interact with the digital world in entirely new ways.
Team Description Join the Quality Team, whose mission is to ensure compliance with relevant regulatory standards. Our experienced professionals use creative problem‑solving to develop efficient systems that support compliance across the product lifecycle.
Job Description and Responsibilities As the Regulatory Affairs Specialist at Neuralink, you will engage with international regulatory bodies throughout clinical evaluation and market introduction, and you will manage compliance and reporting activities in the post‑market phase. Your core responsibilities include:
Evaluate the regulatory environment and provide internal advice throughout the product lifecycle (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 strategies 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 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 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 regulatory filings.
Experience with robotics, software, and cybersecurity‑related regulatory filings.
RAPs or ASQ certification or other scientific/technical training.
Expected Compensation Base salary: $71,000—$119,000 USD. Additional equity compensation in the form of restricted stock units (RSUs) is available to all full‑time employees.
What We Offer
Opportunity to change the world and work with some of the smartest experts across disciplines.
Rapid growth potential for high‑impact contributors.
Comprehensive medical, dental, and vision insurance through a PPO plan.
Paid holidays and commuter benefits.
Meals provided and equity (RSUs) for full‑time employees.
401(k) plan (minimum eligibility after 1,000 work hours for interns).
Parental leave.
Flexible time off.
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Team Description Join the Quality Team, whose mission is to ensure compliance with relevant regulatory standards. Our experienced professionals use creative problem‑solving to develop efficient systems that support compliance across the product lifecycle.
Job Description and Responsibilities As the Regulatory Affairs Specialist at Neuralink, you will engage with international regulatory bodies throughout clinical evaluation and market introduction, and you will manage compliance and reporting activities in the post‑market phase. Your core responsibilities include:
Evaluate the regulatory environment and provide internal advice throughout the product lifecycle (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 strategies 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 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 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 regulatory filings.
Experience with robotics, software, and cybersecurity‑related regulatory filings.
RAPs or ASQ certification or other scientific/technical training.
Expected Compensation Base salary: $71,000—$119,000 USD. Additional equity compensation in the form of restricted stock units (RSUs) is available to all full‑time employees.
What We Offer
Opportunity to change the world and work with some of the smartest experts across disciplines.
Rapid growth potential for high‑impact contributors.
Comprehensive medical, dental, and vision insurance through a PPO plan.
Paid holidays and commuter benefits.
Meals provided and equity (RSUs) for full‑time employees.
401(k) plan (minimum eligibility after 1,000 work hours for interns).
Parental leave.
Flexible time off.
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