Technical Documentation Manager (m/f/d)

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 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

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.