Technical Writer IfU
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
Key Responsibilities
- Create revise and publish high-quality Instructions for Use (IFU) in alignment with current procedures regulatory expectations and market needs.
- Ensure documentation complies with QSR ISO and other internal quality and regulatory standards.
- Coordinate translation activities with external translation agencies and internal stakeholders to ensure linguistic accuracy and timely delivery.
- Maintain adherence to company style guides templates and quality management systems (QMS).
- Collaborate cross-functionally with teams such as Product Development Regulatory Affairs Quality Assurance Marketing and Global Operations to gather information and validate technical accuracy.
- Drive and manage activities within the assigned area of responsibility.
- Contribute to the continous improvement of documentation standards templates and processes.
- Support Deviation CAPA and complaint investigations by providing documentation expertise and contributing to corrective action processes.
Qualifications & Experience
- Bachelors or Masters degree in Technical Communication English Journalism Life Sciences (e.g. Biology Biochemistry Molecular Biology) or a related field; equivalent professional experience will be considered.
- 23 years of technical writing experience within the life sciences medical device or in vitro diagnostics (IVD) industry.
- Excellent English including speaking writing and editing skills.
- Strong understanding of regulated content development including usability risk communication and labeling requirements.
- Hands-on experience with content management systems (CMS/CCMS) ideally in DITA/XML structured authoring environments.
- Proven ability to manage multiple documentation projects in a global fast-paced and regulated environment.
- Experience working with translations and simplified English.
- Experience with EU IVDR documentation requirements.
Preferred Skills
- Proven ability to create clear compliant and user-friendly content for laboratory technicians clinicians and regulatory reviewers.
- Multilingual skills (e.g. German French Spanish) to support localization and translation processes.
- Experience in use of reusable content strategies to drive consistency and efficiency.
- Strong cross-cultural communication and collaboration skills with flexibility to work in a dynamic global team setting.
- High attention to detail accuracy and a commitment to continuous improvement.
- Demonstrated technical curiosity and interest in understanding complex products and systems.
- Good collaborator with clear communication skills.
- Ability to work both independently and in collaboration with others as well as the ability to handle both small and large tasks.
- Experience with EU MDR is an advantage.
Key Skills
- Proofreading
- Adobe Acrobat
- Content Management Systems
- Technical Writing
- Visio
- Microsoft Powerpoint
- Sharepoint
- XML
- Confluence
- Wiki Systems
- Word Processing
- Writing Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
