Job Description

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 Quality Team, where our mission is to ensure compliance with relevant regulatory standards. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance.

& Responsibilities:

As an Internal Auditor, you will be responsible for calling out gaps, communicating findings concisely and directly, remediating gaps, and implementing compliance with the applicable regulatory requirements. Additionally, you will be expected to:

• Conduct audits of Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and engineering activities within Neuralink, ensuring adherence to U.S. FDA regulatory requirements, any international applicable standards, and Neuralink policies
• Identify and define audit scope and criteria, review evidence, analyze findings to assess compliance levels, and provide recommendations for improvement and corrective actions as needed
• Perform root-cause analysis to identify compliance gaps and risks, providing results to leadership for further action
• Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills
• Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating timely closure of actions
• Lead the front room for external audits (e.g., FDA or other notified bodies)

Required Qualifications:

• Bachelor's degree in a relevant scientific, engineering, or healthcare field
• 2+ years of experience as an auditor
• Experience being part of external agency audits (e.g., FDA or other notified bodies)
• Working knowledge of FDA regulatory requirements and standards
• Excellent communication and collaboration abilities

Preferred Qualifications:

• Engineering background
• Experience conducting audits for GLP, GMP, and GCP
• Experience with international regulatory audits (e.g., TGA, EU, Health Canada, MDSAP)
• Experience with supplier audits
• Experience leading an internal audit program
• Experience being a front room lead for external agency audits

Expected Compensation:

At Neuralink, your base pay is one part of your total compensation package. The anticipated base salary for this position is expected to be within the below range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training.

What We Offer:

Full-time employees are eligible for the following benefits listed below.

• An opportunity to change the world and work with some of the smartest and most talented experts from different fields
• Growth potential; we rapidly advance team members who have an outsized impact
• Excellent medical, dental, and vision insurance through a PPO plan
• Paid holidays
• Commuter benefits
• Meals provided
• Equity + 401(k) plan *Temporary Employees & Interns excluded
• Parental leave *Temporary Employees & Interns excluded
• Flexible time off *Temporary Employees & Interns excluded

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