Technical Writer - Instructions for Use (IFU)

As a Technical Writer at Thermo Fisher Scientific, you will play a crucial role in creating, revising, and publishing high-quality Instructions for Use (IFU) in alignment with current procedures, regulatory expectations, and market needs. Your responsibilities will include:

• Ensuring documentation compliance with QSR, ISO, and other internal quality and regulatory standards.
• Coordinating translation activities with external agencies and internal stakeholders to ensure linguistic accuracy and timely delivery.
• Maintaining adherence to company style guides, templates, and quality management systems (QMS).
• Collaborating cross-functionally with teams such as Product Development, Regulatory Affairs, Quality Assurance, Marketing, and Global Operations to gather information and validate technical accuracy.
• Driving and managing activities within the assigned area of responsibility.
• Contributing to the continuous improvement of documentation standards, templates, and processes.
• Supporting Deviation, CAPA, and complaint investigations by providing documentation expertise and contributing to corrective action processes.

To qualify for this role, you should have:

• A Bachelors or Masters degree in Technical Communication, English, Journalism, Life Sciences, 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 skills, including speaking, writing, and editing.
• Strong understanding of regulated content development, 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 for this role include:

• Ability to create clear, compliant, and user-friendly content for laboratory technicians, clinicians, and regulatory reviewers.
• Multilingual skills to support localization and translation processes.
• Experience in using reusable content strategies to drive consistency and efficiency.
• Strong cross-cultural communication and collaboration skills in a dynamic, global team setting.
• High attention to detail, accuracy, and commitment to continuous improvement.
• Technical curiosity and interest in understanding complex products and systems.
• Good collaborator with clear communication skills.
• Ability to work independently or in collaboration with others and handle tasks of varying sizes.
• Experience with EU MDR is an advantage.

This position is at a Senior Level, and you will have the opportunity to contribute significantly to the development of critical documentation within a dynamic and innovative environment. As a Technical Writer at Thermo Fisher Scientific, you will play a crucial role in creating, revising, and publishing high-quality Instructions for Use (IFU) in alignment with current procedures, regulatory expectations, and market needs. Your responsibilities will include:

• Ensuring documentation compliance with QSR, ISO, and other internal quality and regulatory standards.
• Coordinating translation activities with external agencies and internal stakeholders to ensure linguistic accuracy and timely delivery.
• Maintaining adherence to company style guides, templates, and quality management systems (QMS).
• Collaborating cross-functionally with teams such as Product Development, Regulatory Affairs, Quality Assurance, Marketing, and Global Operations to gather information and validate technical accuracy.
• Driving and managing activities within the assigned area of responsibility.
• Contributing to the continuous improvement of documentation standards, templates, and processes.
• Supporting Deviation, CAPA, and complaint investigations by providing documentation expertise and contributing to corrective action processes.

To qualify for this role, you should have:

• A Bachelors or Masters degree in Technical Communication, English, Journalism, Life Sciences, 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 skills, including speaking, writing, and editing.
• Strong understanding of regulated content development, 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 req