HUMAN provides safe laboratory diagnostics in over 160 countries. How do we do this? With reliable reagents and analysis systems, and with employees who strive to be customer oriented and to contribute to the improvement of global healthcare. Look forward to a midsize company where you have enough room for initiative and the joy of decision-making.

For the next possible date, we are looking to hire an

Junior Technical Documentation Manager (m/f/d)

Located in Wiesbaden

YOUR KEY RESPONSIBILITIES:

• Creation, review, maintenance, and revision of technical and scientific documentation for IVD product files in accordance with IVDR (EU 2017/746), the IVD Directive, and other applicable regulatory requirements - with the goal of achieving and maintaining the Declaration of Conformity.
• Management of product files in the eDMS.
• Participation in projects such as IVDR implementation and product development projects.
• Revision of process-related documentation and close collaboration with internal departments including Regulatory Affairs, Product Management, International Registration, Clinical Affairs, Risk Management, and Post-Market Surveillance.
• Support in updating process-relevant SOPs and associated document templates.
• Provision of customer-relevant information for internal departments and external partners.
• Preparation of scientific reports including partial analysis of product-specific analytical and clinical data and their association. interrelations

• Successfully completed studies in a technical or scientific discipline (e.g., Chemistry, Biochemistry, Biology, Biotechnology, Medical Technology) or a comparable qualification.
• Initial practical experience in the areas of Quality Assurance/Management, Regulatory Affairs, or Scientific/Medical Writing or technical documentation - ideally in the field of in vitro diagnostics (IVD) - is a plus.
• Basic knowledge of regulatory requirements (e.g., IVDR, ISO 13485, ISO 14971) is appreciated.
• Strong understanding of scientific principles as well as experience in analyzing and evaluating scientific and clinical data.
• Excellent command of English, both written and spoken.
• Confident use of Microsoft 365 tools.
• A high level of commitment, team spirit, willingness to learn, and a structured, detail-oriented, and results-driven working style.

• Permanent employment contract
• Employer subsidy for company pension scheme
• Employer-financed private supplementary health insurance
• HUMAN working life model
• Flexible working hours and the option to work partially from home
• JobRad (bicycle leasing)
• Free fruit and beverages
• Free use of e-charging stations and car parks
• Further training opportunities