Associate Director, Labeling - Technical Writer

Responsibilities 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 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 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 Communicate effectively with senior‑level stakeholders and international partners, ensuring alignment and timely delivery of all documentation commitments Requirements 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 Extensive experience in regulated industries such as medical devices or pharmaceuticals, with deep knowledge of regulatory compliance and documentation requirements 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) #J-18808-Ljbffr Jobtailor