Regulatory Affairs Lead

Quality Systems      ·       Fremont, California       ·       Full time

As the Regulatory Affairs Lead at Neuralink, you will be a part of the Quality Systems team responsible for regulatory affairs activities and interactions with the FDA during clinical evaluations and/or market introduction as well as compliance and reporting activities in the post-market phase. The position is also responsible for developing regulatory approaches for devices under development, advising for clinical evaluations, preparing pre-market regulatory submissions, and posting approval reports.

Key Responsibilities:

• Prepare and submit US product filings Q-Subs, IDE, PMA, non-filing justifications, CE technical files. 
• Ensures compliance of submissions with all applicable regulations, guidance, and SOPs for regulatory submissions.
• Assess the impact of product and design changes on the regulatory pathway.
• Support product engineering team with documentation reviews.
• Write and update SOPs, policies, and work practices.
• Ensure Medical Device Technical Files are accurate and updated in compliance with requirements.
• Provide guidance and interpretation on regulatory compliance issues related to FDA sprint discussions.
• Support FDA and notified body audits as needed.

Key Qualifications:

• Bachelor’s Degree or higher in an applicable science or engineering discipline.
• 5+ years of professional experience.
• Minimum two years of experience in submissions and technical documentation (PMA, Supplements, technical documentation).
• Strong understanding of design controls and verification/validation activities.
• RAPs or ASQ certification or other scientific/technical training.
• Experience with robotics, software, and cybersecurity-related regulatory filings is preferred.

What we offer:

• An opportunity to change the world and work with some of the smartest and the 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; parental leave.
• Flexible time off + paid holidays.
• Equity + 401(k) plan.
• Commuter Benefits.
• Meals provided.

Neuralink provides equal opportunity in all of our employment practices to all qualified employees and applicants without regard to race, color, religion, gender, national origin, age, disability, marital status, military status, genetic information or any other category protected by federal, state and local laws.  This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social, and recreational programs. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

Multiple studies have found that a higher percentage of women and BIPOC candidates won’t apply if they don’t meet every listed qualification. Neuralink values candidates of all backgrounds. If you find yourself excited by our mission but you don’t check every box in the description, we encourage you to apply anyway!