Change Control & Regulatory Affairs Specialist

Project overview

For our client in the medical technology sector, we are looking for a Change Control & Regulatory Affairs Specialist in the greater Frankfurt am Main area.

Project details

immediately

Until the end of December 2026 (with option for extension)

Greater Frankfurt am Main area

20h/week

Job Description

Profile

• You will create, manage, and track change control processes in the document management system, currently SmartSolve.
• You will support the departments involved in the change process with technical and procedural questions.
• You will monitor the change control process using defined KPIs and process metrics.
• You will regularly evaluate open and overdue tasks and track their processing status.
• You will participate in COC meetings and support the coordination of ongoing changes.
• You will organize and facilitate regular coordination meetings on currently open changes based on open tasks.
• You will create training materials for the change control process and train the involved employees.
• You will ensure the timely implementation of corrective and preventive actions within your area of responsibility.
• You will be responsible for and maintain the Change Management SME documentation.
• You will create, update, and review technical documentation for manufactured medical devices.
• You will administratively compile the required components of the technical documentation.
• You will review and approve labels, instructions for use, and other product-related documents.
• You will create and update regulatory documents to meet the requirements of MDD and MDR, such as GSPR documentation.
• You will create or update declarations of conformity.
• You will make released documents available on customer-accessible platforms and keep them up-to-date.
• You will provide documentation for international or foreign registrations as needed.
• You will take on tasks as a Document Controller and maintain or upload documents in the document management system.
• You have experience with change control processes in a regulated environment, ideally in the medical device sector.
• You have practical experience with document management systems, ideally SmartSolve or comparable systems.
• You have a good understanding of CAPA, Nonconformance, and Risk Management processes.
• You have experience in monitoring KPIs and quality-relevant process metrics.
• You have knowledge of project management and can systematically coordinate and track open actions.
• You have good knowledge of the EU Medical Device Regulation MDR (EU) 2017/745.
• You have knowledge of the Medical Device Directive (MDD), especially in relation to legacy products.
• You have experience in creating, reviewing, and maintaining technical documentation for medical devices.
• You have knowledge in the area of conformity assessment and declarations of conformity.
• You have sound knowledge of ISO 13485 and quality management systems in the medical device environment.
• You are familiar with the creation or maintenance of regulatory documents such as GSPR, instructions for use, and product labeling.
• You work in a structured, careful, and documentation-oriented manner and can reliably coordinate multiple ongoing change processes.
• Start: 2026-11
• Duration: 2 Monate
• Remote: onsite
• Location: Hessen, Deutschland, DE
• Languages: German