Associate Director, Labeling & Technical Writer

Associate Director, Senior Technical Writer Job Summary

The Associate Director, Senior Technical Writer is a strategic documentation leader responsible for driving the development, quality, and evolution of technical documentation for Class II medical devices. This role combines deep expertise in technical writing with strong people leadership, cross‑functional influence, and operational excellence. The ideal candidate brings extensive regulatory experience, excellent communication skills, and the ability to lead a high‑performing team while collaborating across diverse business functions.

• Lead, develop, and mentor a team of technical writers, illustrators, and/or documentation specialists; provide coaching, performance feedback, and career development.
• Build a high‑performing documentation function by establishing clear expectations, aligning team goals to organizational priorities, and fostering a culture of quality, accountability, and continuous improvement.
• Oversee resource planning, workload balancing, and vendor/contractor management as needed.
• Represent the documentation function in leadership forums and influence decisions affecting product development, quality, labeling, and regulatory deliverables.

• Own the end‑to‑end documentation lifecycle for customer‑facing and internal technical content including user manuals, IFUs, installation guides, troubleshooting guides, upgrade/downgrade instructions, and documentation for global regulatory submissions.
• Ensure compliance with FDA, EU MDR, ISO 13485, and other relevant standards; embed regulatory and quality requirements into documentation workflows.
• Establish, maintain, and enforce documentation standards, best practices, templates, and style guides across all product lines.
• Drive documentation quality through consistent editorial review, standardization, and improvement of content clarity, structure, and usability.

• Partner with engineering, quality assurance, regulatory affairs, clinical/medical affairs, marketing, customer support, and global business units to gather information, validate content, and align documentation with product requirements.
• Lead the creation and review of IFU design specifications and quality documentation, collaborating with subject matter experts to ensure clinical and regulatory accuracy.
• Serve as the documentation authority in cross‑functional meetings, influencing project scope, timelines, and risk mitigation strategies.
• Communicate effectively with senior‑level stakeholders and international partners, ensuring alignment and timely delivery of all documentation commitments.

• Create and edit technical documents with a high degree of accuracy, clarity, and regulatory compliance.
• Develop visual content including diagrams, illustrations, flow charts, line art, and product photography; advise engineering teams on data visualization and content usability.
• Stay current on industry trends, regulatory developments, and advancements in technical communication tools and methodologies.

• Manage documentation schedules, dependencies, resource requirements, and deliverables within fast‑paced project environments.
• Drive process improvements to increase efficiency, reduce cycle times, and enhance documentation quality.
• Oversee version control, change management, and documentation integration within enterprise systems.

• Bachelor’s degree in Technical Communication, Engineering, or a related technical or communications field required.
• 7+ years of experience in technical writing, technical communication, or documentation development required.
• 5+ years of experience within a regulated industry (medical devices strongly preferred; pharma/biotech acceptable).
• 3+ years of people leadership experience, including managing writers, contractors, or cross‑functional documentation teams required.

• Master’s degree in Technical Communication, Regulatory Science, Engineering, Biomedical Engineering, Life Sciences, or a related…