This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

HistoSonics is seeking a Technical Communications Manager to lead the development, maintenance, and lifecycle management of product labeling and related controlled documentation. This role is responsible for day-to-day labeling strategy, planning, and execution across product development and commercial activities, ensuring content is clear, accurate, compliant, and delivered on schedule. This position will focus heavily on IFUs and labeling for new indications, including expansion into new therapeutic areas.

• Lead the development, revision, and lifecycle management of labeling and related controlled documentation, including IFUs, eIFUs, quick-start guides, labels, and other user-facing product documentation.
• Manage day-to-day labeling priorities, timelines, and deliverables across product changes, feature updates, market expansion activities, and future indications.
• Create labeling content for new products, features, workflows, and indications, and revise existing documentation as products evolve.
• Work proactively with cross-functional teams to identify, obtain, and clarify the information needed to support accurate, compliant documentation.
• Drive cross-functional review cycles, consolidate feedback, support approval and release readiness.
• Lead and collaborate with labeling team members across writing, document development, layout, and related activities.
• Help build team capability, strengthen labeling processes and procedures, and support scalable documentation practices.
• Support translation and global labeling activities to help ensure consistency, accuracy, and release readiness across markets.

Qualifications

• Bachelor’s degree in Technical Writing, Technical Communication, a related field, or equivalent professional experience.
• 5+ years of experience developing medical device labeling and related documentation in a regulated environment.
• Experience managing or leading a team.
• Experience managing labeling projects and coordinating cross-functional input across Regulatory, Quality, R&D, Clinical, and related teams.
• Demonstrated experience developing IFUs and labeling in compliance with applicable regulatory requirements, quality system requirements, and medical device standards.
• Experience creating clear, accurate, and compliant content for new and evolving product features, workflows, and indications.
• Experience with document control and change management processes, including revision documentation, changelogs, and controlled updates using document control systems such as Grand Avenue Software or similar platforms.
• Working knowledge of document layout and production tools such as Adobe InDesign, FrameMaker, or similar publishing systems, and ability to become proficient in Adobe InDesign and related workflows as needed.

Requirements

• Travel up to 15%.

Benefits

• Comprehensive benefits package for full-time employees.
• Health, dental, and vision insurance.
• Life, short-term and long-term disability insurance.
• 401(k).
• Paid time off.
• More benefits available.