Technical Writer, Product Development
Skills
Attention To DetailDocument ManagementDocument ReviewEditingEstablishing Strategic PartnershipsOperationsPresentations
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Master’s or Ph.D. in Life Sciences Biomedical Sciences Biomedical Engineering or relevant field
- 3-5 years of technical writing experience in regulated medical devices pharmaceuticals or closely related regulatory or quality documentation
- Experience preparing and editing FDA-facing documents such as Pre-Sub/Q-Sub submissions PMA-supporting documentation meeting packages or formal agency responses
- Strong command of scientific and technical writing with the ability to synthesize complex multidisciplinary content
- 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
- Ability to work with cross-functional subject matter experts and manage multiple document timelines in a fast-paced environment
- Strong organizational communication and project coordination skills
- Working knowledge of regulatory expectations and industry standards relevant to IVD and medical device development
Nice to have
- NGS diagnostics
- Liquid biopsy
- Oncology diagnostics
- cfDNA methylation
Day to day
- Draft, edit, format, and maintain FDA-facing technical documents for regulated NGS-based diagnostic products.
- Partner with cross-functional subject matter experts to gather inputs and translate complex technical information into submission-ready content.
- Coordinate document review cycles and controlled-document workflows while maintaining traceability, consistency, and compliance with QMS requirements.