Technical & Regulatory Writer

New York, NY        ·       Full-time

Description

We are seeking a Technical and Regulatory Writer to help write regulatory submissions and other documentation related to our medical device brain-computer interface.

Our goal is to improve the lives of patients who live with neurological disorders and to do so in a matter of months and years, not decades.

This position can be based in either our NYC or Mountain View (CA) office and is for full-time employment. 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.
• With the input of our external regulatory consultants and our highly accomplished technical team, create and maintain regulatory submissions including clinical trial applications, IRB and IDE submissions, pre-submission inquiries, 510(k) and PMA applications.
• Collaborate with the rest of our team to create documents such as grant submissions and whitepapers.
• Work in a deeply collaborative manner across our business including with Quality, Product, R&D, Clinical, Marketing and Manufacturing staff.
• Monitor newly published FDA guidelines and international guidance documents.
• Communicate project updates on progress, risks, options, barriers and recommendations to technical and non-technical audiences.

Requirements

• Expert at communicating complex technical ideas clearly and effectively.
• 3+ years’ expertise writing regulatory documentation for medical devices, such as 510(k) applications, IRB and IDE submissions, PMA applications and clinical trial applications.
• Has a background in neuroscience 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, close-knit team.

Please click here to apply.