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Regulatory Affairs Lead

Employer
Neuralink
Location
Fremont, CA
Start date
Jul 19, 2022
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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.

Responsibilities:

  • 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.

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.
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