Technical Writer

GxP Recruitment; Galway; On-site; EUR 42,000 - 65,000; Full time

Job summary

GxP Recruitment is seeking a Technical Writer to craft clear, compliant documentation for medical devices in Ireland. You will translate complex technical information into user manuals, guides, and packaging inserts for diverse audiences, including healthcare professionals and regulators.

Collaborating with product management, R&D, regulatory affairs, and QA, you will ensure accuracy, update content with product changes, and uphold high quality standards across documentation suites.

Qualifications

• Excellent writing, editing, and proofreading skills.
• Understanding of medical device terminology, design, and functionality.
• Familiarity with regulations and standards for medical devices.
• Strong communication and interpersonal skills to work with cross-functional teams.
• Meticulous attention to detail to ensure accuracy and consistency in documentation.

Responsibilities

• Producing user manuals, package inserts, technical guides, and other documentation related to medical devices.
• Collaborating with cross-functional teams (product management, R&D, regulatory affairs, QA) to gather information and ensure accuracy.
• Ensuring documentation adheres to relevant regulations and standards for medical devices.
• Maintaining and updating documentation to reflect product changes, new regulations, or user feedback.
• Quality assurance through rigorous review and testing processes.

Skills

Technical Writing

Medical Devices

Regulatory Knowledge

Communication

Attention to Detail

Software Proficiency

Tools

Microsoft Word

Adobe Acrobat

XML editors

Job description

Technical writer

A Technical Writer in the medical device industry is crucial for creating clear, accurate, and regulatory-compliant documentation that supports the development, use, and maintenance of medical devices. They translate complex technical information into easily understandable language for various audiences, including users, healthcare professionals, and regulatory bodies.

Key Responsibilities:

Documentation Creation:

Producing user manuals, package inserts, technical guides, and other documentation related to medical devices.

Collaboration:

Working closely with cross-functional teams (e.g., product management, R&D, regulatory affairs, quality assurance) to gather information and ensure accuracy.

Regulatory Compliance:

Ensuring all documentation adheres to relevant regulations and standards, such as those set by the FDA or other regulatory bodies.

Content Updates:

Maintaining and updating documentation to reflect product changes, new regulations, or user feedback.

Quality Assurance:

Ensuring the quality and accuracy of all technical documentation, often through rigorous review and testing processes.

Skills and Qualifications:

Technical Writing Skills:

Excellent writing, editing, and proofreading skills, with the ability to adapt writing style to different audiences.

Knowledge of Medical Devices:

Understanding of medical device terminology, design, and functionality.

Regulatory Knowledge:

Familiarity with relevant regulations and standards for medical devices.

Communication and Collaboration:

Strong communication and interpersonal skills to work effectively with various teams.

Attention to Detail:

Meticulous attention to detail to ensure accuracy and consistency in documentation.

Software Proficiency:

Experience with relevant software for documentation creation and management (e.g., Microsoft Word, Adobe Acrobat, XML editors).