Regulatory Engineer

Team Description:

Join the Regulatory Team, where our mission is to enable global access to Neuralinks 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:

• Bachelors 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.