Our client is an innovative MedTech company developing cutting-edge, non-invasive diagnostic solutions. Their technology leverages advanced sensing methods to transform how chronic conditions are monitored, with a mission to make healthcare more accessible, painless, and patient-friendly on a global scale.

The role

In this position, you will join as a Technical Writer, taking ownership of critical technical and clinical documentation across the product lifecycle. You will play a central role in supporting product development, regulatory submissions, and quality processes, ensuring all documentation is accurate, compliant, and audit-ready. Working closely with cross-functional teams, you will translate complex technical and regulatory information into clear, structured documentation that supports both internal development and external approvals.

Key responsibilities

• Lead the authoring, structuring, and maintenance of technical documentation, including design history files, risk management files, test plans, and reports.
• Own and manage documentation within the Quality Management System (QMS), ensuring compliance with global standards and regulatory requirements.
• Collaborate with cross-functional teams (engineering, QA/RA, clinical, and leadership) to gather and translate complex technical information.
• Develop and refine documentation supporting clinical studies, ensuring clarity, traceability, and regulatory compliance throughout the lifecycle.
• Identify documentation gaps and drive continuous improvement of documentation processes and standards.
• Ensure all documentation is audit-ready and supports regulatory submissions and approvals.
• Act as a subject matter expert for documentation, guiding teams to produce high-quality, compliant outputs.

Required experience and qualifications

• Strong background in medical device development within a regulated environment.
• Hands-on experience with medical device standards and regulations such as ISO 13485, ISO 14971, IEC 60601, IEC 62304, ISO 14155, and FDA regulations (21 CFR 820, 21 CFR Part 11).
• Proven experience creating and managing technical documentation across the product lifecycle.
• Experience supporting clinical documentation, including study submissions, execution, and close-out.
• Strong understanding of software, hardware, and/or electronics sufficient to collaborate with technical teams and produce detailed documentation.
• Familiarity with QMS processes and document control best practices.
• Excellent ability to translate complex technical concepts into clear, concise, and structured documentation.
• Strong written and verbal communication skills in English.

Why this role?

• Join a highly innovative MedTech company working on breakthrough, patient-centric technology.
• Be part of a multidisciplinary, collaborative team of experts across engineering, science, and clinical domains.
• Play a critical role in bringing transformative healthcare solutions to market.
• Work in an environment that values quality, precision, and continuous improvement.
• Opportunity to make a tangible impact on global healthcare outcomes.