Technical Writer R&D (Medical Devices)

De Bilt - Netherlands

Monthly Salary: EUR 5000 - 5400

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

We are looking for a Technical Writer to join our R&D department and support the generation of high-quality documentation throughout the medical device design and development process. The role focuses on developing and maintaining technical pre-clinical and clinical documents that form part of the Design History File (DHF) and provide essential input for worldwide regulatory submissions.

The ideal candidate has a solid understanding of design controls risk management and the medical device regulatory landscape ensuring that all R&D deliverables meet ISO 13485 QSR and internal quality system requirements.

Key Responsibilities

Author edit and maintain R&D documentation in alignment with design control processes including design inputs/outputs verification and validation protocols/reports human factors engineering and risk management documentation (per ISO 14971).
Develop and maintain technical clinical and biological evaluation documents (e.g. CEP/CER BEP/BER) in close collaboration with key stakeholders.
Design and conduct systematic literature searches.
Write and maintain the Instructions for Use (IFUs) and other labeling documentation in line with the intended purpose of Kuros products.
Identify appraise and analyze relevant clinical PMS marketing and testing data from multiple sources and create comprehensive scientific and technical reviews.
Ensure consistency traceability and compliance across DHF elements and other R&D documentation.
Support cross-functional teams by compiling data literature and technical summaries to substantiate the safety and performance of Kuros products.
Contribute to the continuous improvement of R&D documentation templates and processes within the QMS

You will be part of the R&D team working with R&D scientists and technicians on the development of implantable medical devices in the musculoskeletal field. Working closely with other stakeholders within the company like QA/RA process engineers and medical/clinical affairs.

Skills and abilities desired:

You have a technical or scientific degree (MSc or Ph.D.) in chemistry (medical) biology biomedical technology or similar;
Minimal 3-5 years of working experience with writing technical documents for high risk medical devices (class III implantable combination products);
Knowledge of global Medical Device Regulations (EU MDR FDA TGA etc.);
Direct experience with writing design related documentations (e.g. risk management human factors design V&V);
Knowledge of combination product development and associated submission deliverables including documentation required to support regulatory submissions;
Pragmatic accurate analytical enjoying the dynamics of dealing with several stakeholders business processes regulatory and clinical challenges;
Strong organizational skills detail-oriented to deal with different projects at the same time;
Must be able to work well independently as well as being able to work cooperatively in a team of professionals
Fluent in English both verbally and in writing;
Legally able to work in The Netherlands.
Residence in the Netherlands

Why Kuros Biosciences

Join an international innovative company with a diverse and energetic team. At Kuros youll work in a positive and collaborative environment contributing to the development of life-changing products. We offer great benefits a competitive salary and opportunities for career growth.

Required Experience:

Manager

Position OverviewWe are looking for a Technical Writer to join our R&D department and support the generation of high-quality documentation throughout the medical device design and development process. The role focuses on developing and maintaining technical pre-clinical and clinical documents that f...