Universal DX
Healthcare
TechnicalWriter
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Technical Writer at Universal DX. Skills: Technical writing, FDA submissions, Regulated medical devices, QMS documentation. Draft, edit, format, and maintain FDA-facing technical documents. Partner with subject matter experts to gather inputs”
Industry & Context.
Root cause analysis; Troubleshooting
What They're Looking For.
Must Have
Master's or Ph. D. in Life Sciences, Biomedical Sciences, Biomedical Engineering, or relevant field, 3-5 years technical writing experience supporting regulated medical devices (IVDs), pharmaceuticals, or other highly regulated, Demonstrated experience preparing and editing FDA-facing documents, Command of scientific and technical writing, Experience supporting controlled documents in a QMS environment, Excellent document management skills, Proven ability to work effectively with cross-functional subject matter experts, Organizational, communication, and project coordination skills, Working knowledge of regulatory expectations and industry standards relevant to IVD and medical device development
Nice to Have
Prior experience with technical writing in the realm of NGS-based diagnostics, Experience with Pre-Sub/Q-Sub submissions, PMA-supporting documentation, meeting packages, or formal agency responses, 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
What You'll Do.
and maintain FDA-facing technical documents
Partner with subject matter experts to gather inputs
Support document planning
Support preparation and revision of controlled documents
Review technical content for clarity
Help structure narratives describing assay design
Coordinate document review cycles and reconcile comments
Contribute to presentation materials for FDA teleconferences
Maintain adherence to QMS requirements and document-control practices
Support continuous improvement of technical writing templates and
How You'll Work.
Team & Collaboration
Cross-functional teams; Product Development; Quality Assurance; Regulatory Affairs; Biostatisticsioinformatics; Laboratory Operations; IVD Software Development
Communication Scope
Technical documentation; Written communications; Presentation materials
Process & Methodology
Document planning, Version control, Document timelines
Full Job Description
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
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