Scientific Technical Writer- Medical Devices- Autoimmunity at Werfen GmbH

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Mar, 26

Salary

46.0

Posted On

09 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Writing, Biotech, Medical Devices, IVD Documentation, Design Control Processes, Document Control Systems, Verification & Validation, CAPA Processes, Quality Management Systems, Attention to Detail, Organizational Skills, Communication Skills, Microsoft Office, Regulatory Standards, Independent Work, Project Management

Industry

Medical Equipment Manufacturing

Description

Overview Job Summary 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. Responsibilities Key Accountabilities 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. Networking/Key relationships R&D teams: Assay Development and Biomarker discovery Manufacturing and Operations Teams Quality & Regulatory Teams Global Systems Support Software and Hardware Teams (within Werfen or external) Qualifications Minimum Knowledge & Experience for the position: 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. Skills & Capabilities: 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. Travel requirements:None required. The hourly range for this role is currently $36.00 range to $46.00 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com

Responsibilities

The Scientific Technical Writer will develop, edit, and maintain technical documentation for Biotech IVD instrumentation and reagent projects. This includes authoring CAPAs, V&V reports, and ensuring compliance with regulatory standards.