Change Control & Regulatory Affairs Specialist

Project overview

We are looking for a Change Control & Regulatory Affairs Specialist for a nationwide position starting on 16.11.2026.

In this role, you will be responsible for the administration and monitoring of change control processes in our document management system. You will support the involved departments with technical and procedural questions and monitor the process using defined KPIs and process metrics. You will regularly evaluate open and overdue tasks, participate in change control meetings, and organize regular coordination meetings for ongoing changes. You will also create training materials and train the involved employees.

In the area of Regulatory Affairs, you will be responsible for the creation, updating, and review of technical documentation for medical devices. You will administratively compile the required components, review and release labels, instructions for use, and product-related documents. You will create and update regulatory documents to meet the requirements of MDD and MDR, create declarations of conformity, and provide documentation on customer-supported platforms. As a Document Controller, you will maintain the document management system.

You have extensive experience with change control processes in regulated environments, ideally in the medical device sector. You have practical experience with document management systems and a good understanding of CAPA, Nonconformance, and Risk Management processes. Knowledge of KPI monitoring, project management, and structured coordination of open actions is required. You possess in-depth knowledge of the EU Medical Device Regulation MDR, the Medical Device Directive MDD, ISO 13485, and quality management systems in the medical device environment.

Experience in creating and maintaining technical documentation and conformity assessments is necessary.

Project details

• Start: 16.11.2026 / ab sofort
• Duration: 2 Monate
• Remote: remote
• Location: Frankfurt am Main, DE
• Languages: German