The Senior Technical Writer creates and maintains end-user documentation for medical devices, ensuring compliance with regulatory standards such as FDA and ISO.
With at least 5 years of experience in the medical device or in vitro diagnostics industry, they possess expertise in structured documentation, version control, and regulatory requirements.
Proficient in MadCap Flare and familiar with industry standards, they handle complex projects independently, collaborate cross-functionally, and contribute to process improvements.
Key responsibilities include developing accurate, consistent documentation, researching technical issues, providing leadership and mentorship, and managing project milestones.
Required qualifications include a degree in English or Technical Writing, strong communication skills, and familiarity with QMS and global labeling standards.
Preferred skills include knowledge of Adobe tools and regulatory requirements beyond the US.
The role offers a salary range of $90,100 to $153,300 annually, along with comprehensive benefits.