Regulatory Engineer

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 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.