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:
• Develop and author comprehensive technical documents for PMA submissions, including but not limited to: device descriptions, clinical study reports, labeling, instructions for use (IFU), risk management files, and quality system documentation.
• Collaborate with cross-functional teams, including regulatory affairs, R&D, clinical operations, and quality assurance, to gather information and ensure accuracy in all submissions.
• Review, edit, and revise documents for clarity, consistency, compliance with FDA guidelines (e.g., 21 CFR Part 820, ISO 13485), and alignment with company standards.
• Conduct research on regulatory requirements specific to in vitro diagnostic (IVD) devices for CRC screening, incorporating updates from FDA guidance documents.
• Manage document lifecycle, including version control, formatting, and preparation for electronic submissions via the FDA's eCTD system.
• Support post-submission activities, such as responding to FDA queries, deficiency letters, and amendments.
• Ensure all documentation adheres to good documentation practices (GDP) and is free of errors, ambiguities, or inconsistencies.
• Assist in developing user manuals, training materials, and other supporting documents for internal and external stakeholders.
What you'll bring:
• Bachelor's degree in scientific or closely related field; advanced degree preferred.
• At least 3-5 years of experience as a Technical Writer in the medical device or diagnostics industry, with direct involvement in FDA regulatory submissions (PMA experience highly desirable).
• Strong understanding of FDA regulations for Class III devices, including PMA processes (GMP and GCP highly desirable), IVD labeling requirements, and clinical evaluation standards.
• Proficiency in technical writing tools such as Microsoft Word, Adobe Acrobat, and document management systems (e.g., MasterControl, QT9).
• Excellent written and verbal communication skills, with the ability to simplify complex technical and scientific concepts for diverse audiences.
• High attention to detail, organizational skills, and the ability to manage multiple projects under tight deadlines.
• Familiarity with CRC screening technologies or oncology diagnostics is a plus.
Preferred Qualifications
• Certification in medical writing (e.g., AMWA) or regulatory affairs (e.g., RAC).
• Experience with diagnostic assays, biomarker development, or molecular diagnostics.
• Knowledge of international regulatory standards (e.g., EU MDR/IVDR) for potential global submissions.
• Prior work on high-risk devices involving clinical trials or human factors engineering.
What we'll offer:
• 22 days of PTO with the possibility to carry over 10 days to the following year.
• Company Holidays, plus your Birthday off!
• Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).
• Flexible work schedule
• And more to come!
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.
