RA Technical Writer

About our Company: 

Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers. 

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 throughout life cycle. Reporting to the VP of regulatory affairs, the technical reviewer/writer will play a critical role in supporting the PMA submission process for our Class III diagnostic 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. As part of the team, you will be in a Company that aims more than to become one 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:

 Why Now? 

This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships.  

We are looking for passionate changemakers to be a part of our journey in this expansive time for us.