Clinical and Regulatory Lead

Team Description:

As Clinical and Regulatory Lead at Neuralink, you will work with the engineering teams to decide and execute the most efficient regulatory pathways to market for our devices, and the clinical trials needed to support them. You’ll also be responsible for continuing to build and oversee the team that runs the day-to-day operations of our clinical trials. We’re looking for someone that is excited to find creative ways of helping Neuralink get the benefit of our devices to people both safely and quickly.

You’ll join as the lead of an existing clinical team of 5 members, and will be starting early on in Neuralink’s regulatory and clinical trial progression.

Job Responsibilities and Description:

• Work with the leadership on the choice of regulatory pathways and corresponding clinical trial design
• Ensure Neuralink studies are in compliance with regulations and standards for clinical research
• Collaborate with engineering and preclinical leads on US and international regulatory filings
• Assess the impact of product and design changes on the regulatory strategy and pathway
• Maintain a working knowledge of and assure compliance with Good Clinical Practice, Federal Regulatory requirements and best practice guidance, and Neuralink SOPs
• Dedicated to the highest standards of clinical trial design and management and always looking for innovation opportunities in this space
• Meticulous attention to detail and organizational skills
• Great verbal and written communication skills
• Resourceful, flexible, and adaptable; no task is too big or too small
• Ability to thrive in a dynamic and constantly changing environment
• Ability to work effectively and collaboratively in a cross-disciplinary team environment
• Willing and eager to go above and beyond/flexible schedule
• Can provide both the 10,000 foot view as well as the day-to-day boots on the ground oversight associated with clinical operations
• Mission-driven and able to meet tight deadlines with accuracy and efficiency

Key Qualifications:

• 5+ years of professional experience
• Minimum two years of experience in regulatory submissions and technical documentation and working knowledge of FDA regulations related to clinical studies
• Understanding of the clinical trial process from beginning to end including: experience managing interactions with regulatory bodies, site identification through closeout, CRO management experience both within the US and abroad
• Strong engineering, scientific, and medical vocabulary and acumen

Preferred qualifications :

• Demonstrated knowledge in medical device regulation and reimbursement pathways
• Experience with robotics, active implantable devices, software, and/or cybersecurity-related regulatory filings
• Experience with class II or III medical devices