Medical Device Technical Writer - Labelling & Manuals

Ascendpm; Dublin; On-site; EUR 60,000 - 75,000; Full time

Job summary

Ascend PM in Dublin is seeking a seasoned Technical Writer to join our medical device team. You will develop operator manuals and technical documents for state-of-the-art software solutions and GUI updates, ensuring clarity and regulatory alignment.

The role demands 5+ years of experience, excellent writing and editing skills, and the ability to translate complex engineering content into user-friendly language while collaborating across regulatory, quality, clinical and engineering teams.

Qualifications

• Five (5) plus years Technical Writing experience.
• Demonstrated experience of producing medical device labelling content compliant with US and/or EU regulations and standards.
• Ideally experience using common technical writing tools (e.g., Adobe Creative Suite and MS Word, Excel, PowerPoint etc.).
• Knowledge of documentation quality management systems is desirable. Mastercontrol experience is an advantage.
• Excellent problem-solving methodology, using industry-accepted concepts and tools to solve complex problems in creative and effective ways.
• Comfort working in fast-paced, results-driven environments with tight timelines and frequent changes.

Responsibilities

• Develop and edit medical device labelling content (user manuals, device labels) that is easy to read for end users.
• Collaborate within a cross-functional team (Regulatory Labelling, Quality, Clinical, Human Factors, Commercial, Engineering, Regulatory) to optimize labelling clarity and completeness.
• Translate technical jargon into user-friendly language to ensure documentation is accessible to a diverse audience.
• Extract relevant information from complex engineering documentation for use in clinical instructions, including working autonomously with limited direction.
• Understand regulatory requirements for medical device labelling, and develop labelling to meet these.
• Research new operator manuals, modifications to existing manuals, technical bulletins and other written material. Edit documentation written by others.
• Develop labeling for all medical devices and accessories.
• Stay up to date with product updates/changes, collaborating with development teams to ensure accurate and timely documentation
• Work within the defined company processes to ensure compliance.
• Conduct reviews and updates of existing documentation to reflect changes in software or hardware configurations.
• Support external language translations.

Skills

Technical Writing

Regulatory compliance knowledge

Editing

MS Word

Adobe Creative Suite

PowerPoint

Tools

Adobe Creative Suite

MS Word

Excel

PowerPoint

Job description

Ascend PM in Dublin is seeking a seasoned Technical Writer to join our medical device team. You will develop operator manuals and technical documents for state-of-the-art software solutions and GUI updates, ensuring clarity and regulatory alignment.

The role demands 5+ years of experience, excellent writing and editing skills, and the ability to translate complex engineering content into user-friendly language while collaborating across regulatory, quality, clinical and engineering teams.