HUMAN Diagnostics is an internationally operating company in the field of in-vitro diagnostics, headquartered in Wiesbaden, Germany. Our products and solutions contribute to medical care in over 160 countries worldwide. As a medium-sized international company, we 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.

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 KEY RESPONSIBILITIES:

- 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 recent 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

YOUR MINDSET AND SKILLS:

- 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

WHAT WE OFFER:

We offer a large room of freedom for your personal development in an open and challenging environment. HUMAN is characterized by short decision processes and a good working atmosphere. If you are interested in shaping your own success, send us a compelling CV including your desired salary.

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.

- Hannah Krüger

- HR Business Partner

📌 Technical Documentation Manager (m/f/d) (Delhi)
🏢 Human Gesellschaft für Biochemica und Diagnostica mbH
📍 Delhi