Associate Director, Labeling & Technical Writer

Associate Director, Senior Technical Writer

This role is a strategic operations leader responsible for transforming and scaling the technical documentation and labeling function. The Associate Director will drive end-to-end process redesign, standardization, and automation across documentation and labeling workflows to improve cycle time, quality, and compliance. The Associate Director, Senior Technical Writer is a strategic and results-oriented documentation leader responsible for designing and 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, process design, cross-functional influence, and operational excellence, and continuous improvement. This leader owns the operating model for documentation—establishing governance, metrics, and tooling that enable predictable, high-quality delivery in a regulated environment while partnering cross-functionally to integrate documentation seamlessly into product development.

Key Responsibilities:

• Lead, develop, and mentor a team of technical writers, illustrators, and/or documentation specialists; provide coaching, performance feedback, and career development.
• Oversee the labeling function, ensuring packaging and IFU content processes are standardized, compliant, and integrated with regulatory and manufacturing workflows
• Design and build a high-performing, best in class documentation function by establishing clear expectations, aligning team goals to organizational priorities, and fostering a culture of quality, accountability, and continuous improvement.
• Drive consistency and efficiency across labeling change control, translations, and global deployment.
• Oversee resource planning, workload balancing, and vendor/contractor management as needed.
• Represent the documentation function in executive leadership forums and own functional updates while influencing decisions affecting product development, quality, labeling, and regulatory deliverables.

Documentation Strategy & Labeling Operations / Process Excellence

• Own and standardize the end-to-end documentation and labeling lifecycle, ensuring seamless integration with product development, design controls, and regulatory submission workflows.
• Have deep rooted knowledge in industry standards and ensure compliance with FDA, EU MDR, ISO 13485, and other relevant standards; embed regulatory and quality requirements into documentation workflows.
• Establish scalable, standardized frameworks for content creation, review, and approval to enable content reuse, reduce variability, and support global regulatory needs.
• Implement quality systems and upstream controls to drive "right-first-time" documentation and reduce downstream review cycles.

Cross-Functional Influence & Collaboration

• 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.
• Serve as the documentation authority in cross-functional meetings, influencing project scope, timelines, and risk mitigation strategies.
• Communicate effectively and confidently with senior-level stakeholders and international partners, ensuring alignment and timely delivery of all documentation commitments.

Content Creation & Technical Expertise

• Create and edit technical documents with a high degree of accuracy, clarity, and regulatory compliance. Foster a team with the same sense of rigor in their review standards.
• Develop modern 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.

Program & Project Management

• Manage documentation schedules, dependencies, resource requirements, and deliverables within fast-paced project environments. Utilize data-driven metrics to drive program decisions and timelines.
• Revamp the functional team to drive process improvements to increase efficiency, reduce cycle times, and enhance documentation quality.
• Oversee version control, change management, and documentation integration within enterprise systems.

Required Qualifications

• 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.

Preferred Qualifications

• Master's degree in Technical Communication, Regulatory Science, Engineering, Biomedical Engineering, Life Sciences, or a related discipline
• Prior leadership of technical writing teams within a medical device organization.
• Extensive experience in regulated industries such as medical devices or pharmaceuticals, with deep knowledge of regulatory compliance and documentation requirements.
• Demonstrated leadership experience managing teams or cross-functional documentation programs.
• Strong collaboration skills working with engineering, marketing, clinical, quality, and regulatory teams.
• Proven ability to manage multiple complex projects under tight deadlines.
• Strong initiative, problem-solving skills, and ability to work independently with minimal supervision.
• Familiarity with electro-mechanical systems and software applications.
• Experience with device labeling and packaging content.
• Knowledge of engineering change control processes and Agile methodologies.
• Experience with ERP systems such as SAP or Oracle.
• Proficiency with version control systems (Perforce, Subversion, TFS, GitHub).
• Skilled in technical editing tools (Microsoft Word, Acrobat, editorial symbols).
• Proficiency with DTP tools (MadCap Flare, Adobe FrameMaker, InDesign, Illustrator, XML, DITA).
• Experience with photography and image editing (Adobe Photoshop).
• Experience working with global regulatory submissions and country-specific documentation requirements.