Technical Writer

Job Title: Technical Writer

Overview:

We are seeking a highly detail-oriented and experienced Technical Writer with a strong background in the technology domain to join our growing team. In this role, you will be responsible for developing, standardising, and maintaining high-quality documentation that supports our medical devices and digital health solutions. Your work will play a critical role in ensuring compliance with regulatory standards and enhancing user experience for clinicians, technicians, and patients.

Key Responsibilities

•   Develop and maintain clear, accurate, and user-centered documentation, including:

Clinical user manuals , Operator guides ,  Software and hardware instructions , Installation and configuration guides ,Regulatory documentation 

• Work closely with cross-functional teams including R&D, Regulatory Affairs, Clinical Affairs, QA, and Product Management to gather and validate technical information.
•  Translate complex technical and clinical information into structured, understandable content for various user personas, including healthcare professionals and internal stakeholders.
• Ensure all documentation adheres to applicable regulatory and quality standards, including ISO 13485, HIPAA, GDPR ,FDA requirements.
• Create and maintain document control processes using version management tools and Quality Management Systems
• Contribute to usability testing and incorporate feedback to continuously improve documentation clarity and usefulness.
• Participate in internal and external audits related to product documentation.Required Qualifications
• Bachelor’s or Master’s degree in Biomedical Engineering, Life Sciences, Technical Communication, or a related discipline.
• Good knowledge of MedTech regulatory standards and best practices for documentation.
• Proficient in writing for a regulated environment with experience producing Standard Operating Procedures, Instructions for Use and validation documentation.
• Familiarity with tools such as Microsoft Office Suite, Confluence, or similar.
• Experience with document control systems and eQMS platforms
• Exceptional attention to detail and ability to manage multiple priorities under strict timelines.

Preferred Qualifications

• Certification in Regulatory Writing, Medical Writing, or Technical Communication
• Experience with SaMD (Software as a Medical Device) or digital health applications.
• Knowledge of API documentation or software development workflows (Agile) is advantageous.
• Familiarity with visual content creation tools

Location

Employment Type: