The Senior Technical Writer specializes in creating, revising, and maintaining end-user documentation for medical devices in compliance with FDA, ISO, and other regulatory standards.
They work independently and collaboratively across teams to ensure accurate, consistent, and high-quality documentation using MadCap Flare, with experience in regulated environments and structured content development.
Responsibilities include managing complex projects, improving documentation processes, researching industry standards, and providing technical leadership and mentorship.
Qualifications include a Bachelor’s degree in English or Technical Writing, at least 5 years of experience in medical device documentation, proficiency in MadCap Flare, and knowledge of regulations such as FDA and ISO.
Preferred skills include familiarity with global labeling requirements and additional tools like Adobe FrameMaker.
Core competencies involve attention to detail, project management, cross-functional collaboration, and regulatory awareness.
Compensation ranges from $90,100 to $153,300 annually, plus benefits.