Process Consultant – Medical Technology

Project overview

For our client in the GR Frankfurt area, we are looking for a Process Consultant – Medical Technology.

Responsibilities

• Analysis and optimization of regulatory processes and contract structures
• Execution of gap analyses of existing processes, interfaces, and contracts
• Assessment of process and contract compliance with applicable medical device regulations
• Development of regulatory-compliant process and contract concepts
• Technical advice on contract design and contract negotiations
• Coordination with specialist departments and relevant stakeholders
• Conception and evaluation of effectiveness checks of completed audit measures
• Creation of analyses, status reports, and recommendations for action

Requirements

Utilization: 30%

• Several years of experience in quality and process management in regulated industries, particularly medical technology or pharmaceuticals
• Sound knowledge of ISO 13485
• Experience in the assessment and design of regulatory-relevant contract structures
• Knowledge of international sales and supply chain processes
• Knowledge of South African medical device regulations, especially the Medicines and Related Substances Act 101 and Regulations No. 1515
• Experience with gap analyses, process optimization, and audit measures
• Very good written and spoken German and English skills

Project details

• Start: November 2026
• Duration: 3 Monate
• Remote: hybrid
• Location: GR Frankfurt, Germany, DE
• Languages: German