Technical Documentation Manager (m/f/d)

HUMAN Gesellschaft für Biochemica und Diagnostica-mbH; Delhi; On-site; INR 900,000 - 1,350,000; Full time

Job summary

HUMAN Diagnostics is hiring a Technical Documentation Manager to create, review, and maintain technical and scientific documentation for IVD products in India. The role focuses on ensuring conformity under IVDR and applicable standards, with responsibilities spanning document management, cross-functional collaboration, and involvement in regulatory projects.

The candidate should hold a degree in a relevant scientific field and have experience in technical writing, regulatory affairs, or related

Qualifications

• Degree in biology/biotech/biochem/chemistry or comparable scientific field.
• Experience in technical documentation, scientific/medical writing, or regulatory affairs.

Responsibilities

• Create, review and maintain technical and scientific documentation for IVD product files per IVDR and regulatory requirements.
• Manage technical documentation within the electronic document management system.
• Support IVDR transition and new product development projects.
• Prepare scientific reports and evaluate analytical/clinical data.
• Collaborate with regulatory, clinical, product, and registration teams.
• Provide information to internal and external stakeholders; support SOPs and templates.

Skills

Technical writing

Regulatory affairs

IVD standards knowledge

Data interpretation

English proficiency

MS 365

Process improvement

Education

Biology / Biotechnology / Biochemistry / Chemistry degree

Tools

Microsoft 365

Job description

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