Required skills
- Change Management
- Document Management Systems
- SmartSolve
- CAPA
- Risk Management
- KPI Monitoring
- Project Management
- Regulatory Affairs
- Technical Documentation
- MDR 2017/745
- MDD
- Quality Management
- ISO 13485
Languages: German
Job description
The role involves coordinating and managing change control processes within a medical technology company, including document management, process monitoring, and ensuring compliance with regulations.
Project overview
Creation, support, and tracking of changes in the document management system, currently SmartSolve.
Technical assistance for all participants in change processes.
Process monitoring Change Control (KPIs).
Participation in COC meetings.
Training of participants/creation of training materials.
Regular evaluation of overdue tasks (approx. every 1-2 weeks).
Timely implementation of corrective and preventive actions within the area of responsibility.
Responsibility and maintenance of the 1728-Change Management SME.
Monthly meeting to discuss all currently open changes (based on the evaluation of open tasks).
Creation and review of technical documentation for manufactured products.
Administrative compilation of technical documentation.
Review and release of labels, instructions for use, etc.
Creation of documents to fulfill requirements from MDD and MDR (e.g., GSPR).
Creation or updating of declarations of conformity.
Provide and update documents on the website (accessible to customers).
Provide documents for foreign registrations as needed.
Document Controller in the document management system (e.g., uploading documents).
Requirements
Change Management
Experience with change control processes in a regulated environment
Knowledge of document management systems (e.g., SmartSolve)
Understanding of CAPA, Nonconformance, and Risk Management processes
Experience with KPI monitoring and process metrics
Project management skills
Regulatory Affairs / Technical Documentation
Good knowledge of the EU Medical Device Regulation (MDR 2017/745)
Knowledge of the Medical Device Directive (MDD) for legacy products
Experience in creating and maintaining technical documentation
Understanding of conformity assessment procedures
Quality Management
Knowledge of:
ISO 13485
MDR 2017/745
Quality management systems in the medical device environment
Additional Information:
Project No.: 1085080
Job Type: Location: Start: 11/16/2026 Duration: 2 months
Project details
- Start: 16.11.2026
- Duration: 2 Monate
- Location: DE
- Languages: German
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