Regulatory Affairs Specialist

New York, New York, United States           ·         Full-time

Description

Our mission at Precision Neuroscience is to develop and commercialize brain-computer interfaces (BCI). We are pursuing minimally invasive approaches to BCI to address major unmet clinical needs. We are well-capitalized and have an IP portfolio that has been built over nearly 10 years.

Brain-computer interfaces represent a new frontier in medicine and computing. We seek to establish Precision Neuroscience as one of the leading companies in this space globally. Our core objective is to deliver life-changing technology to millions of patients worldwide, and in doing so to transform the ways we interact with machines, one another, and our world.

We are seeking a Regulatory Affairs Specialist to write and facilitate regulatory submissions and other technical papers related to our medical device brain-computer interface.

This is an extraordinary opportunity to join our core team to help shape the future of our company. Your work will help our product advance rapidly toward commercialization, so that we improve the lives of patients who live with neurological disorders.

For more detail on our device see our whitepaper: https://www.biorxiv.org/content/10.1101/2022.01.02.474656v1

This position is on-site and can be based in our Mountain View, CA or NYC office. We are unable to consider applicants who are not currently in the US.

Responsibilities:

• Write about our complex brain computer interface (BCI) medical device which includes hardware and software components.
• Interface across all business functions including hardware, software and product management teams to ensure a deep understanding of our device and development timelines.
• With the help of our highly accomplished technical team and external regulatory consultants, write and facilitate regulatory submissions including clinical trial applications, IRB and IDE submissions, pre-submission inquiries, 510(k) and PMA applications.
• Monitor newly published FDA guidelines and international guidance documents.
• Collaborate with the rest of our team on technical manuscripts and academic whitepapers.

Requirements

• Expert at communicating complex technical ideas clearly and effectively.
• 2+ years’ expertise writing regulatory documentation for medical devices (comprising hardware or software), such as 510(k) applications, IRB and IDE submissions, PMA applications and clinical trial applications.
• Has a science background either through education or work experience.
• A self-starter who enjoys working to challenging deadlines.
• A great collaborator who enjoys working as part of a high-performing, friendly, close-knit team.

Diverse workforces create the best culture, company, and products. We at Precision Neuroscience are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Precision Neuroscience does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Please click here to apply.