Junior Technical Documentation Manager (m/f/d)

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

Junior Technical Documentation Manager (m/f/d)

Initially limited until 31.12.2027.

Located in Wiesbaden

Are you looking for a varied role at the interface between Regulatory Affairs and Product Management? Do you have a passion for precise documentation and structured content? Then become part of our team as a Junior Technical Documentation Manager (m/f/d) and bring your skills and enthusiasm to the dynamic field of in-vitro diagnostics.

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