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.
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
More about this role
Based in Mountain View, CA., NeuroPace is a commercial-stage medical device company focused on transforming the lives of people suffering from epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differential RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source.
At NeuroPace, employees are our greatest asset. We are continually searching for solution-oriented individuals who can bring energy and creativity to our growing workforce. At NeuroPace, our success depends upon our ability to recruit and retain the most talented, enthusiastic and dedicated people we can find and providing them with a dynamic and challenging environment in which to thrive.
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.
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