Technical Writer R&D (Medical Devices)

De Bilt - Netherlands

Monthly Salary: € 5000 - 5400

Posted on: 9 hours 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 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;

Designing and conducting systematic literature searches;
Write and maintain the Instructions for Use (IFUs) and other labelling documentation in line with the intended purpose of Kuros products;
Identifying appraising and analyzing all relevant (clinical PMS marketing and testing data) from multiple sources and creating a comprehensive scientific review;

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 safety and performance of Kuros products;
Contribute to 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 (class III implantable) medical devices;
Knowledge of global Medical Device Regulations (EU MDR FDA TGA etc.) particularly in relation to generating and evaluating clinical data of medical devices;
Direct experience with writing clinical documentations;
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.

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...

Position Overview

Key Responsibilities

Author edit and maintain R&D documentation in alignment with design control processes including design inputs/outputs verification and validation protocols/reports 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;

Designing and conducting systematic literature searches;
Write and maintain the Instructions for Use (IFUs) and other labelling documentation in line with the intended purpose of Kuros products;
Identifying appraising and analyzing all relevant (clinical PMS marketing and testing data) from multiple sources and creating a comprehensive scientific review;

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 safety and performance of Kuros products;
Contribute to continuous improvement of R&D documentation templates and processes within the QMS.

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 (class III implantable) medical devices;
Knowledge of global Medical Device Regulations (EU MDR FDA TGA etc.) particularly in relation to generating and evaluating clinical data of medical devices;
Direct experience with writing clinical documentations;
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.

Required Experience:

Manager