About This Role
This role involves developing and managing controlled procedures, work instructions, and forms within a regulated environment. The Technical Documentation Specialist/Technical Writer will collaborate with subject matter experts to translate complex technical information into clear, accurate, and consistently structured documentation, overseeing it through review, approval, and release.
Responsibilities
- Collaborate with subject matter experts through meetings, interviews, and working sessions to define and validate document content
- Translate complex technical information into clear, concise, and logically structured procedures, work instructions, forms, and supporting documents
- Identify content gaps, ask effective clarification questions, and incorporate feedback
- Review documentation for technical accuracy, clarity, consistency, terminology, and formatting
- Apply templates, good documentation practices, and document-control requirements throughout drafting, review, approval, and release
- Plan and manage priorities, timelines, document status, risks, and dependencies with minimal supervision
- Track and communicate documentation progress and performance metrics
- Support continuous improvement of documentation templates and authoring processes while contributing effectively to the wider team
Requirements
- A qualification in Engineering, Information Systems, Life Sciences, Technical Communication, Languages, or a related discipline
- A broad technical foundation and the ability to understand and communicate complex subject matter
- Excellent technical writing, editing, and proofreading skills
- Advanced Microsoft Word skills, including styles, templates, tables, numbering, and document formatting
- Experience creating controlled documentation in a regulated industry and applying good documentation practices
- Strong verbal communication, active listening, interviewing, and clarification skills
- Excellent attention to detail, accuracy, and consistency
- Strong planning, organization, and time-management skills, with the ability to work independently
- Ability to track and report documentation metrics
- Self-motivated team player with strong interpersonal and cross-functional collaboration skills
Nice to have:
- Experience in the medical device, pharmaceutical, or another highly regulated industry
- Knowledge of ISO 13485 or comparable standards and regulated quality systems
- Experience with validation documentation, electronic document or quality management systems including Windchill, and controlled change workflows
- Experience contributing to formal, public, or published reports
