The Opportunity:

As Technical Writer, you will be responsible for the preparation and management of all regulatory documents associated with the federal submission of Signal-C throughoutlife cycle. Reporting to the VP of regulatory affairs, thetechnical reviewer/writerwill play a critical role in supporting the PMA submission process for our Class IIIdiagnostic device focused on CRC screening. This position involves creating, editing, and managing technical documentation to meet FDA regulatory requirements, including detailed reports on device design, clinical data, risk analysis, and manufacturing processes. The ideal candidate is detail-oriented, experienced in medical device regulations, and adept at translating complex scientific information into precise, accessible content.

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers.Aspart of the team, you will be in a Company that aims more thanto becomeone of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".

How you'll contribute: