Connecting brains and machines for a better future
Neuralink, headquartered in Fremont, CA, is pioneering ultra-high bandwidth brain-machine interfaces aimed at restoring autonomy for individuals with paralysis. With $1.3 billion raised in Series D funding, the company has completed human trials after securing FDA approval in 2023, marking a signifi...
Neuralink offers excellent medical, dental, and vision insurance through a PPO plan, flexible time off, and paid holidays. Employees also benefit from...
Neuralink fosters a culture of innovation and ambition, focusing on groundbreaking technology that merges neuroscience with engineering. The company v...
Neuralink • Austin, Texas, United States
Neuralink is hiring a Regulatory Affairs Specialist to ensure compliance with regulatory standards for innovative brain interface devices. You'll engage with international regulatory bodies and develop regulatory strategies throughout the product lifecycle. This role requires expertise in regulatory affairs and compliance.
You have a strong background in regulatory affairs, ideally with experience in medical devices or related fields. You understand the complexities of regulatory compliance and have a proven track record of interacting with regulatory bodies. Your analytical skills allow you to evaluate regulatory environments and anticipate potential challenges. You are detail-oriented and can prepare comprehensive regulatory submissions that meet stringent guidelines. You thrive in collaborative environments and enjoy working with cross-functional teams to ensure product compliance throughout the lifecycle.
Experience with clinical evaluations and post-market compliance is a plus. Familiarity with international regulatory standards and guidelines will enhance your ability to navigate complex regulatory landscapes. You are proactive in identifying regulatory obstacles and proposing effective solutions. A background in the development of medical devices or similar technologies will be beneficial in this role.
As a Regulatory Affairs Specialist at Neuralink, you will be responsible for overseeing regulatory activities related to our innovative brain interface devices. You will engage with international regulatory bodies during clinical evaluations and market introductions, ensuring that all submissions are compliant with applicable regulations. Your role will involve developing regulatory strategies for devices under development, preparing pre-market submissions, and creating post-approval reports. You will evaluate product classifications and determine the necessary regulatory submission requirements and approval pathways. Additionally, you will contribute to the development and implementation of new regulatory procedures to enhance compliance processes. You will work closely with the Quality Team to ensure that all regulatory activities align with our mission to revolutionize human interaction with technology.
At Neuralink, we provide excellent medical, dental, and vision insurance through a PPO plan, along with paid holidays and commuter benefits. Meals are provided to our team members, and we offer equity in the form of RSUs. We also have a 401(k) plan available for our employees, with parental leave and flexible time off policies. Join us in our mission to create groundbreaking technology that has the potential to change lives.
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