Scientific Technical Writer- Medical Devices- Autoimmunity

Werfen • San Diego, CA

14d • $36 - $46

About The Position

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.

Requirements

• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees