Kuros Biosciences

Medical writer

• Support the full design and development lifecycle, from early concept through verification, validation, and regulatory submission for class III medical devices and combination products
• Support the development, review, and maintenance of Design History File (DHF) documentation throughout all stages of the design process, including design inputs/outputs, verification and validation protocols/reports, and risk management documentation
• Collaborate with the project team to structure, format, and refine core design control deliverables, ensuring clarity, consistency, traceability and compliance with quality system requirements
• Participate in design reviews and risk management activities with relevant stakeholders
• Support design teams during development activities, ensuring documentation aligns with technical progress and regulatory expectations
• Develop and maintain technical, clinical, and biological evaluation documentation
• Develop and contribute for the preparation of documentation specific to combination products to support early interactions with the FDA and other regulatory bodies
• Conduct systematic literature reviews to support safety and performance claims
• Compile risk management documentation in accordance with ISO 14971
• Contribute to development of Instructions for Use (IFUs) and product labeling
• Support preparation of documentation required for global regulatory submissions (EU MDR, FDA, and other markets)

Technical Writer – Medical Devices, Combination Products