Scientific Technical Writer- Medical Devices- Autoimmunity

Werfen-posted 1 day ago
$36 - $46/Yr
Full-time • Mid Level
San Diego, CA
5,001-10,000 employees
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The Scientific Technical Writer will be responsible for creating, editing, and maintaining high-quality documentation for Biotech IVD instrumentation and reagent projects. This includes authoring and revising CAPAs (Corrective and Preventive Actions), V&V (Verification & Validation) reports and protocols, and other quality and regulatory documents. The position supports the R&D and Quality teams by ensuring all documentation meets internal standards and regulatory requirements.

  • Develop, edit, and maintain technical documentation, including CAPAs, V&V reports, protocols, and quality documents for in-vitro diagnostic instruments.
  • Collaborate with R&D, Quality, Manufacturing, and Regulatory teams to gather information and ensure accuracy and completeness of documentation.
  • Ensure all documents comply with company procedures, regulatory standards, and design control requirements.
  • Participate in document reviews, audits, and updates as required.
  • Support the creation and maintenance of Design History Files (DHF) and other records as needed.
  • Translate complex scientific concepts into clear, concise, and accurate documentation for internal and external audiences.
  • Communicate effectively with cross-functional teams to clarify requirements and resolve documentation issues.
  • Bachelor’s in Life Sciences, Engineering, or related field (Master’s a plus). At least 3 years’ technical writing experience in biotech, medical device, or IVD sectors.
  • Experience with design control processes and document control systems.
  • Familiarity with V&V documentation, CAPA processes,and quality management systems.
  • Strong attention to detail, organizational, and communication skills
  • Proficiency with Microsoft Office (Word, Excel, Acrobat).
  • Experience with in-vitro diagnostics or medical device documentation.
  • Knowledge of regulatory standards (FDA, ISO 13485, etc.).
  • Ability to work independently
  • Ability to manage priorities across multiple projects simultaneously.
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