06 Nov
|
HUMAN Diagnostics Worldwide
|
Gurugram
06 Nov
HUMAN Diagnostics Worldwide
Gurugram
For the next possible date, we are looking to hire a Technical Documentation Manager (m/f/d). Located in India
- Fixed term until 31 December 2029 We are looking for a reliable and motivated colleague who enjoys working with scientific information, pays attention to detail, values collaboration and is fascinated to learn and develop within a highly regulated environment. YOUR IMPACT:
• Create, review and maintain technical and scientific documentation for IVD product files in accordance with the IVD Regulation (EU) 2017/746 and other applicable regulatory requirements to achieve and maintain product conformity
• Manage technical documentation and product files within the electronic document management system
• Support strategic projects, including IVDR transition and new product development projects
• Prepare scientific reports and evaluate analytical and clinical performance data
• Collaborate with Regulatory Affairs, Clinical Affairs, Product Management, and International Registration, Production, Quality Control, Research & Development
• Provide process-, product
- and documentation-related information to internal stakeholders and external partners
• Support the maintenance and continuous improvement of SOPs, document templates, and related quality management documentation YOU BRING:
• A degree in Biology, Biotechnology, Biochemistry, Chemistry, Medical Technology, or a comparable scientific field
• Initial experience in Technical Documentation, Scientific or Medical Writing, Regulatory Affairs, or a related area
• Basic knowledge of IVDR, ISO 13485, and further relevant IVD standards
• A strong scientific mindset and an interest in evaluating and interpreting analytical and clinical data
• Excellent written and spoken English
• Confidence in using Microsoft 365
• Structured, precise, and solution-oriented working style
• Strong organizational skills and attention to detail
• High level of motivation, willingness to learn, and enthusiasm for interdisciplinary teamwork WHY HUMAN?
• We provide reliable laboratory diagnostics in more than 160 countries worldwide, helping improve healthcare through high-quality in vitro diagnostic solutions
• We believe excellent results come from curiosity, collaboration, and continuous learning
• We, as a medium-sized international company, offer the best of both worlds: an international, collaborative environment with the agility to turn ideas into action, empower individual contributions, and make decisions quickly This position is explicitly aimed at talents based in India, working in our India office with the option of working remotely up to 50%. Ready to Grow with Us? Send us your application, including your salary expectations and earliest possible starting date.
📌 Technical Documentation Manager (Gurugram)
🏢 HUMAN Diagnostics Worldwide
📍 Gurugram