06 Nov
|
HUMAN Diagnostics Worldwide
|
India
06 Nov
HUMAN Diagnostics Worldwide
India
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 setting. 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
📌 Technical Documentation Manager (India)
🏢 HUMAN Diagnostics Worldwide
📍 India