Change Management and Technical Documentation Specialist

Project overview

We are looking for an experienced professional in Change Management and Technical Documentation within the regulated medical device environment. In this role, you will be responsible for the creation, management, and tracking of changes in our document management system. You will provide technical support to all participants in change processes, monitor KPIs, and actively participate in change control meetings.

Your tasks include training employees and creating corresponding training materials. You will conduct regular evaluations, monitor deadlines, and implement corrective and preventive actions on time. Furthermore, you will be responsible for maintaining the Change Management area and moderating monthly meetings on open changes.

In the area of technical documentation, you will create and review documentation for manufactured products. This includes the administrative compilation, review, and release of labels and instructions for use. You will create documents to fulfill MDR and MDD requirements, update declarations of conformity, and make them available on the customer website. If necessary, you will prepare documentation for foreign registrations and act as a Document Controller in the document management system.

You bring extensive experience with change control processes in a regulated environment and are familiar with document management systems. You understand CAPA, Nonconformance, and Risk Management processes as well as KPI monitoring. Your knowledge of the EU Medical Device Regulation (MDR 2017/745) and the Medical Device Directive (MDD) is profound. You have experience in creating technical documentation, understand conformity assessment procedures, and are familiar with ISO 13485 and quality management systems in the medical device sector.

Project details

• Start: 16.11.2026
• Duration: 2 Monate
• Location: DE
• Languages: German