Neuralink
Regulatory Engineer
About this role
Neuralink is seeking a Regulatory Engineer to support regulatory affairs, including interactions with global regulatory bodies, compliance, and reporting. The role involves collaborating with various teams to integrate regulatory requirements and streamline submissions for innovative medical devices.
What you'll do
- Coordinate with R&D and engineering teams on regulatory integration.
- Evaluate device classification and design technical documentation.
- Identify regulatory obstacles and propose creative solutions.
- Prepare regulatory submissions and organize technical evidence.
- Assess design changes for regulatory impact.
- Develop and improve internal compliance tools and training.
What they're looking for
- Bachelor's Degree in relevant engineering field
- Strong technical writing skills
- Excellent collaboration abilities
- Experience in regulatory submissions
- Knowledge of medical device design
- Familiarity with risk management
- Ability to navigate fast-paced environments
- Understanding of global regulatory standards
Benefits
- Opportunity to work on groundbreaking technology
- Growth potential for high-impact team members
- Comprehensive medical, dental, and vision insurance
- Paid holidays
- Commuter benefits
- Provided meals
- Equity compensation (RSUs)
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Neuralink
Neuralink develops brain-computer interface technology and neurosurgical robots to enable direct interaction between the brain and computing systems. The company is hiring engineers across clinical implementation, user interface design, manufacturing, and software development to support its pioneering medical devices and surgical systems.
- Website
- neuralink.com
Likely interview questions
- Walk us through your experience preparing medical device regulatory submissions (IDE, PMA, 510(k), or international equivalents). What was your role, and how did you ensure submissions were complete and compelling?
- Describe a time when you identified a regulatory or compliance obstacle early in a device development project. How did you propose a creative solution that balanced regulatory requirements with development timelines?