Head of Quality Management, Regulatory Affairs

• Responsibility for the further development of our quality management system according to DIN EN ISO 13485
• Introduction and support of certification to DIN EN ISO 27001
• Planning, monitoring, control and improvement of the quality management system across all departments
• Support in maintaining and updating the technical documentation of our medical device
• Development of intelligent workflows for creating, maintaining and reviewing regulatory documentation
• Building an AI-supported management system with Jira and GitHub as central versioning and process platforms
• Integration of AI into quality, risk and documentation processes
• Preparation and execution of internal audits, including tracking of corrective actions
• Conducting quality management training for employees
• Monitoring and implementation of regulatory requirements in collaboration with our Responsible Person
• Preparation and support for the annual MDR surveillance audits and recertifications by the notified body
• Maintaining and further developing our documentation system in consultation with management
• Regular preparation of the Periodic Safety Update Report (PSUR), the clinical evaluation, and the Post-Market Clinical Follow-Up (PMCF) report, including monitoring of required data, and preparing and supporting management for the annual management review

Requirements

• Degree in (Medical) Informatics, Biomedical Engineering, Electrical Engineering or a comparable medical or scientific-technical qualification
• Certified training in quality management (e.g., Quality Management Representative (QMR/QMB), QM auditor or Quality Manager)
• Knowledge of the MDR (EU 2017/745) and national medical device legislation
• Knowledge of DIN EN ISO 13485 and 27001
• Experience with Jira and GitHub is an advantage
• Practical experience conducting internal audits, ideally with an internal auditor certificate

Core Competencies

Demonstrates expertise in quality management systems, particularly in compliance with DIN EN ISO 13485 and DIN EN ISO 27001, while effectively integrating AI into quality and documentation processes. Proficient in conducting internal audits and maintaining regulatory documentation for medical devices.

Highest-signal resume keywords

• Quality Management System Development
• DIN EN ISO 13485 Compliance
• DIN EN ISO 27001 Certification
• Internal Audits Execution
• Regulatory Documentation Management

ATS Optimization Keywords

Hard Skills

• Quality Management
• Regulatory Compliance
• Internal Auditing
• Technical Documentation
• Workflow Development
• AI Integration
• Risk Management
• Data Monitoring
• Clinical Evaluation
• Post-Market Clinical Follow-Up

Soft Skills

• Training Delivery
• Collaboration
• Communication

Certifications & Qualifications

• Quality Management Representative
• QM Auditor
• Quality Manager
• Internal Auditor Certificate

Industry Keywords

• MDR (EU 2017/745)
• Medical Device Legislation
• Periodic Safety Update Report (PSUR)
• Management Review
• Corrective Actions

Tools & Technologies

• Jira
• GitHub