DEKRA is one of the world’s leading testing, inspection, and certification (TIC) companies, offering professional services in a wide variety of industries and technologies. As a purpose-driven organization with over 100 years of history and more than 45,000 employees in 60+ countries, DEKRA is committed to making the world a safer place, on the road, at work, and at home.
DEKRA Medical is a global leader in the certification of high-risk and innovative medical devices, including in-vitro diagnostic (IVD) devices. Operating through two Notified Bodies and one UK Approved Body, we serve customers across six regions. Our work is grounded in compliance, operational efficiency, and continuous improvement.
Position Overview
This role focuses on operational planning and execution in alignment with a wide range of regulatory and business requirements. As the Global Process Owner of the Medical Device Application Process, you will ensure the smooth onboarding of new customers and the compliant, efficient planning and execution of all assessment activities and changes.
Successful process ownership involves:
Meeting both regulatory and business expectations
Applying effective project and change management practices
Optimizing operational and project management workflows across regions and functions
A key focus of this role is leveraging digital tools to:
Strengthen customer communication
Improve data management
Increase planning accuracy and efficiency
Enable real-time monitoring of activities
Working across functions and regions, you will foster a culture of compliance, data-driven decision-making, and operational excellence, contributing directly to the effectiveness and integrity of DEKRA Medical’s certification processes.
Key Responsibilities
Ensure Global Regulatory Compliance: Maintain alignment with ISO 13485, EU MDR, EU IVDR, UKCA, MDSAP, and ISO 17021-1 standards
Drive Operational Excellence: Lead initiatives to improve project management workflows using Lean, Six Sigma, Agile, and Business Process Reengineering (BPR) methodologies
Digital Transformation: Implement digital tools to enhance customer communication, enable real-time data access, and interface with authority databases together with the digitalization team
Data Analytics & Dashboarding: Use analytics to monitor KPIs, generate stakeholder dashboards, and identify performance improvement opportunities
Knowledge Development: Design and deliver training programs ensuring up-to-date knowledge of processes and operational excellence approaches
Operational Support: Provide expert guidance, resolve deviations, and manage escalations
Cross-Functional Collaboration: work with global teams including business managers, project managers, support offices, quality managers, and other process owners to foster innovation and continuous development
