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. You will also be responsible for developing regulatory approaches for devices under development, advising for clinical evaluations, preparing pre-market regulatory submissions, and posting approval reports. Please note that this is not an entry-level position.
- Prepare and submit US product filings Q-Subs, IDE, PMA, non-filing justifications, CE technical files.
- Ensure 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.
- 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.