We are seeking a Technical Writer to create, update, and maintain regulated product content, ensuring it meets approved requirements, templates, content models, quality standards, and regulatory expectations.

This role translates technical, product, regulatory, and stakeholder inputs into clear, accurate, compliant, and user-friendly documentation, including Instructions for Use (IFUs), guides, labelling, digital content, and lifecycle updates.

The successful candidate will support structured content development, review cycles, localisation readiness, formatting, and controlled release activities while escalating complex content architecture or interpretation issues when required.

Key Responsibilities

1. Content Creation & Maintenance

• Create, assemble, and update IFUs, user guides, eHelp, app-related content, and other regulated product documentation.

• Transform technical specifications, usability insights, and regulatory requirements into clear end-user content.

• Ensure documentation accurately reflects product features, intended use, warnings, precautions, limitations, and instructions.

• Develop content using approved templates, terminology, metadata, and style standards.

• Prepare content for review, approval, localisation, publication, and release.

2. Structured Authoring & Content Reuse

• Apply modular content structures, templates, metadata, and reuse principles to support localisation and lifecycle management.

• Identify opportunities to reuse or adapt existing content instead of creating new material.

• Maintain consistency between source content, reusable components, outputs, and translation requirements.

• Use CCMS and authoring tools in line with established processes and governance standards.

• Escalate unclear content ownership, reuse, or structural issues when necessary.

3. Content Quality & Usability

• Review content for clarity, accuracy, completeness, consistency, and usability before formal review.

• Apply plain-language and user-centred writing principles within regulatory requirements.

• Ensure text and visual elements work together to support safe and effective product use.

• Resolve or escalate conflicting, incomplete, or unclear source information.

• Produce high-quality, structured drafts that minimise downstream rework.

4. Review & Stakeholder Management

• Collaborate with Regulatory, R&D, Marketing, Clinical, and other cross-functional teams throughout content reviews.

• Incorporate feedback while maintaining compliance with approved requirements, terminology, and content standards.

• Track review comments, resolve feedback, and escalate conflicting or architecture-related issues.

• Document significant content decisions where traceability is required.

• Support final quality checks before localisation, submission, or release.

5. Localisation & Release Readiness

• Prepare structured source content for translation and localisation workflows.

• Support localisation teams with approved terminology and contextual guidance when required.

• Assess translation impacts, version control implications, and release timelines for content updates.

• Assist with final content validation, document control requirements, and release preparation activities.

6. Process Excellence & Continuous Improvement

• Follow content development, quality, regulatory, and document control procedures.

• Use authoring, workflow, review, and document management systems accurately and consistently.

• Identify process improvement opportunities across content creation, review, translation, formatting, and release workflows.

• Contribute to content standards, reusable assets, checklists, and best practices.

• Participate in training related to structured authoring, CCMS, regulatory labelling, and localisation readiness.

What You'll Bring

Required Experience & Skills

• Experience in technical writing, regulated content, product documentation, instructional content, labelling, localisation, regulatory operations, or similar environments.

• Strong written communication, analytical thinking, stakeholder management, and attention to detail.

• Ability to convert complex technical, product, regulatory, or operational information into clear and structured content.

• Experience working within regulated environments, quality systems, and controlled processes.

• Proficiency in English (written and spoken).

• Ability to develop and maintain controlled content using defined standards, templates, tools, and workflows.

Core Competencies

• Action Oriented – Takes initiative, addresses challenges proactively, and responds quickly to opportunities and issues.

• Manages Ambiguity – Performs effectively in changing environments and seeks clarity when requirements are unclear.

• Nimble Learning – Learns quickly, adapts to new situations, and applies lessons learned to improve outcomes.

• Cultivates Innovation – Proposes creative solutions, explores alternatives, and continuously looks for improvements.

Preferred Experience

• 3-5 years of working experience within medical devices, healthcare, life sciences, software, or other regulated industries.

• Familiarity with CCMS, structured authoring, modular content, terminology management, translation workflows, or content governance.

• Knowledge of EU MDR, ISO 13485, regulatory labelling, usability engineering, or risk-based documentation practices.

• Experience with document management, review, and workflow systems.

Education

• Degree in Technical Communication, Science, Engineering, Biomedical Science, Communications, Linguistics, Education, or a related field.

• Equivalent experience in regulated documentation or technical writing environments will also be considered.