Technical Writer, Product Development

About the role

Universal DX is seeking a Technical Writer to join our growing Product Development team to support the D evelopment 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 , Regulatory Affairs , 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.

Requirements

• 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, or

Benefits

Additional Information

A bout our Company: Universal D X , 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.

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