Technical Writer - Instructions for Use (IFU)

Thermo Fisher Scientific India Pvt Ltd; Bengaluru; On-site; INR 600,000 - 800,000; Full time

Job summary

Thermo Fisher Scientific India Pvt Ltd is hiring a Technical Writer to create, revise, and publish high-quality Instructions for Use (IFUs). The role ensures alignment with regulatory standards and global quality systems, while coordinating translations and maintaining style guides.

You will work with Regulatory Affairs, QA, and Product Development to guarantee technical accuracy and timely delivery. The position requires 2–3 years of technical writing experience in life sciences or IVD, strong

Qualifications

• Bachelor’s or Master’s degree in Technical Communication, English, Journalism, Life Sciences or related field; equivalent experience considered.
• 2–3 years of technical writing experience in life sciences, medical devices, or IVD industry.
• Excellent English writing, editing, and communication skills.
• Understanding of regulated content development including usability, risk communication, and labeling requirements.
• Experience with CMS/CCMS and DITA/XML structured authoring environments.
• Experience with translations and simplified English; knowledge of EU IVDR is a plus.

Responsibilities

• Create, revise, and publish high-quality IFUs aligned with current procedures, regulatory expectations, and market needs.
• Ensure documentation complies with QSR, ISO, and other quality/regulatory standards.
• Coordinate translations with external agencies and internal stakeholders for linguistic accuracy and timely delivery.
• Maintain adherence to company style guides, templates, and QMS.
• Collaborate cross-functionally with Product Development, Regulatory Affairs, QA, Marketing, and Global Operations to validate technical accuracy.
• Drive and manage activities within the assigned area; contribute to continuous improvement of docs standards and processes.
• Support Deviation, CAPA, and complaint investigations with documentation expertise.

Skills

Technical writing

CMS/CCMS

DITA/XML

Editing

English proficiency

Cross-functional collaboration

Regulatory understanding

Education

Bachelor’s or Master’s degree in Technical Communication, English, Journalism, Life Sciences

Tools

CMS/CCMS

DITA/XML

Job description

Technical Writer - IfU Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll 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 world’s 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

• Bachelor’s or Master’s degree in Technical Communication, English, Journalism, Life Sciences (e.g., Biology, Biochemistry, Molecular Biology), or a related field; equivalent professional experience will be considered.
• 2–3 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 t echnical 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.

Experience Level Mid Level