Software Medical Writer

Responsibilities

• Lead the authoring and maintenance of software lifecycle documentation in compliance with IEC 62304, ISO 13485, ISO 14971, and FDA regulations
• Own and maintain software requirements, architecture, design descriptions, verification and validation documentation, and traceability matrices
• Translate software intended use, system behavior, and risk controls into clear, regulator-ready documentation
• Support design control activities including design inputs, outputs, verification, validation, and change management
• Collaborate with Software Engineering and QA teams to ensure documentation accurately reflects implemented functionality and test evidence
• Maintain end-to-end software requirements and verification traceability using requirements management tools such as Jama, Polarion ALM, or DOORS
• Support internal and external audits, inspections, and regulatory submissions with audit-ready documentation

Requirements

• Bachelor’s degree in a scientific, engineering, or technical discipline
• 5+ years of experience in medical, regulatory, or technical writing within regulated environments
• Proven experience documenting medical device software or Software as a Medical Device (SaMD)
• Strong understanding of software development lifecycle (SDLC), verification, and validation concepts
• Hands-on experience with standards such as IEC 62304, ISO 13485, ISO 14971, and FDA design controls
• Experience working within Quality Management Systems (QMS/eQMS) and formal document control processes
• Excellent written communication skills with strong attention to detail

Preferred Qualifications

• Experience implementing ISO 13485 and 21 CFR Part 820 quality system requirements
• Background in software development with a grasp of core engineering principles and Git-based version control
• Experience documenting connected devices, mobile applications, and cloud-connected medical software
• Familiarity with Agile or hybrid development environments
• Experience authoring risk management files and validating user-facing labeling or instructions for use (IFU)

About the Company

Analog Devices, Inc. (ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare.