# Sr. Regulatory Affairs Manager at NeuroPace

- Company: NeuroPace
- What the company does: The NeuroPace RNS System is the only FDA-approved epilepsy device that delivers personalized treatment by responding to abnormal brain activity and provides EEG data that can help improve patient care. Backed by NEA.
- Company website: https://www.neuropace.com/
- Type: Startups
- Level: Senior
- Location: Mountain View, California
- Work setup: On-site
- Pay: $160K to $190K base salary per year (USD)
- Posted: 2026-08-28
- Apply by: 2026-10-12
- Apply: https://www.neuropace.com/about-neuropace/neuropace-careers/?gh_jid=6145888004
- Page: https://www.1752.vc/careers/jobs/neuropace-sr-regulatory-affairs-manager/

## About the role

We are currently seeking a Senior Regulatory Affairs Manager to join our team. This is a hybrid position based in the Mountain View, CA office 2-3 days a week. This individual will be responsible for regulatory support for new product development, sustaining, and clinical study projects and related submissions for a highly technical and complex active implantable US Class III medical device system.

## What they're looking for

- Bachelor’s degree in a scientific or technical discipline required, advanced degree and/or professional certification(s) preferred
- 6-8 years' of regulatory affairs medical device industry experience required, with at least 3 years of people management preferred
- Thorough understanding and extensive experience with FDA regulations, PMA experience required. Experience with international regulations preferred
- Working understanding of highly technical and complex active implantable medical device systems, including hardware and software, is required
- Demonstrated experience with the regulatory requirements for specialized technical disciplines, including cybersecurity, artificial intelligence, and machine learning preferred
- Extensive knowledge of product development process and design controls, and an excellent grasp of change control and verification and validation requirements

Tags: Regulatory
