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:
Universal DX is seeking a Technical Writer to join our growing Product Development team to support the Development and commercialization of Next Generation Sequencing (NGS)-based in vitro diagnostic products for early cancer detection. This role will be responsible for authoring, editing, and coordinating high-quality technical documents that support FDA-facing regulatory interactions and internal design-control activities.
This is an individual contributor role for a technical writer with relevant experience supporting regulated medical device and/or IVD documentation, including FDA Pre-Sub/Q-Sub packages, PMA-supporting documentation, and controlled quality system documents. The role requires strong relevant technical knowledge, excellent document organization, and the ability to translate complex cross-functional input into clear, submission-ready content.
This is a remote role with regular cross-functional engagement. The Technical Writer will support the Product Development organization directly, while also partnering with stakeholders from Quality Assurance, RegulatoryAffairs, and other Universal DX functions.
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:
• Draft, edit, format, and maintain FDA-facing technical documents, including Pre-Sub/Q-Sub packages, teleconference slides, meeting minutes, and written responses to agency feedback.
• Partner with subject matter experts across Product Development, Automation Development, Regulatory Affairs, Quality Assurance, Biostatistics/Bioinformatics, Laboratory Operations, and IVD Software Development to gather inputs required for generating submission-ready documents.
• Support document planning, content integration, version control, and formatting for cross-functional deliverables, ensuring traceability, consistency of terminology, and alignment across sections and appendices.
• Support preparation and revision of controlled documents within the UDx quality management system, including protocols, procedures, work instructions, reports, forms, design-control records, CAPAs, change-control documentation, and verification/validation protocols and reports, as needed across Product Development, Quality, and other functions.
• Review technical content for clarity, completeness, internal consistency, grammar, formatting, and alignment with document templates, style conventions, and regulatory expectations.
• Help structure narratives that describe assay design, analytical validation, workflows, software outputs, acceptance criteria, and risk-related content for regulated audiences.
• Coordinate document review cycles, reconcile comments from multiple stakeholders, and move documents to timely approval while maintaining accurate revision history, document metadata, and document-control requirements within template, or electronic quality management system (QMS) workflows.
• Contribute to presentation materials and other written communications used for FDA teleconferences, internal governance reviews, and external regulatory discussions.
• Maintain adherence to QMS requirements and document-control practices, and support continuous improvement of technical writing templates, standards, and authoring workflows.
What you’ll bring:
Required Qualifications
• Master’s or Ph.D. in Life Sciences, Biomedical Sciences, Biomedical Engineering, or relevant field.
• 3-5 years of technical writing experience supporting regulated medical devices (IVDs), pharmaceuticals, or other highly regulated products; or a combination of technical writing and closely related regulatory or quality documentation experience in a regulated environment. Prior experience with technical writing in the realm of NGS-based diagnostics is a strong plus.
• Demonstrated experience preparing and editing FDA-facing documents, preferably including Pre-Sub/Q-Sub submissions, PMA-supporting documentation, meeting packages, or formal agency responses, as part of a cross-functional team.
• Strong command of scientific and technical writing, with the ability to synthesize complex multidisciplinary content into concise, organized, and audience-appropriate documents.
• Experience supporting controlled documents in a QMS environment, including SOPs, protocols, reports, forms, procedures, and design-control documentation.
• Excellent document management skills, including version control, comment reconciliation, template use, formatting discipline, and attention to detail.
• Proven ability to work effectively with cross-functional subject matter experts and manage multiple document timelines in a fast-paced environment with appropriate guidance on priorities and review pathways.
• Strong organizational, communication, and project coordination skills, with the ability to support document development from outline through approval.
• Working knowledge of regulatory expectations and industry standards relevant to IVD and medical device development, including FDA submissions, design controls, validation/verification documentation, and controlled-document practices.
Preferred Qualifications
• Experience supporting NGS-based assays, liquid biopsy products, oncology diagnostics, and/or cfDNA methylation technologies.
• Familiarity with analytical validation, verification/validation, design history file content, and documentation that supports FDA PMA submissions.
• Experience using document management, EDMS, eQMS, or collaboration platforms to support controlled-document workflows, change history, approval routing, and cross-functional review cycles across departments.
What we´ll offer:
We’re proud to offer exceptional corporate benefits which include:
• 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!
