21.10.2026 aktualisiert
Premiumkunde
100 % verf眉gbarEU-MDR & AI Act Compliance | SAP Healthcare | Digital Health | Quality Assurance/Test Management
Berlin, Deutschland
Weltweit
Bachelor of Business Administration (HU) / Bachelor of Applied Science (Hochschule Niederrhein)脺ber mich
EU-MDR 路 ISO 13485 路 GAMP5 路 QMS 路 SAP S/4HANA 路 SAP CLM 路 Digital Transformation 路 Healthcare IT 路 Regulatory Affairs 路 Azure Cloud 路 Power BI 路 Agile 路 Scrum 路 PMO 路 DevOps 路 ISTQB 路 ITIL 路 Compliance Management 路 SaaS 路 Data Engineering 路 Cloud Security 路 ISO Audit 路 SAP CALM 路
Skills
SAP EHSBusiness Process ManagementSaasCloud-SicherheitComplianceGlobal Information Assurance CertificationISO / IEC 27001Release-ManagementSAP TRMAda ComplianceSAP COSAP Customizing/KonfigurationSAP GRCSAP ImplementierungSAP MDM
Regulatory Compliance & Cloud Security
Extensive knowledge of regulatory compliance and cloud security according to ISO 9001, EU-MDR, GAMP 5 and ISO/IEC 27001.
SAP Test Management & Cloud Migration
In-depth experience in SAP test management with the modules CALM, MM, SD, PS and BI. Support for complete application migrations from on-premises to SAP-based cloud environments including validation, traceability and release management.
Digital Transformation & Cloud Architecture
Proven expertise in implementing digital transformation projects and migrating legacy systems to modern cloud-native architectures on Microsoft Azure and AWS. Control of distributed, cross-regional development teams and complete SDLC support.
Quality Management Systems
Knowledge of quality management systems according to ISO 9001, ISO/IEC 27001 and ISO/IEC 25010.
Agile & DevOps Leadership
Experience in agile project management with Scrum and Kanban as well as DevOps methods such as CI/CD, Jira and automation. Create quality dashboards to track sprint velocity and test automation level.
Data & AI Governance
Knowledge of data and AI governance as well as Responsible AI. Deploy AI-powered clinical workflow solutions with SLM, LLM, and prompt engineering.
Data Analysis & Reporting
Use of Power BI and Azure Data for data analysis and reporting. Create quality dashboards and operational performance reports for technical management and stakeholders.
Risk management
Conduct risk assessments for cloud environments, applications, customer data, and servers/databases. BSI IT-Grundschutz knowledge including risk analysis, security measures and ISMS.
Stakeholder Management & Auditing
Experience in stakeholder management towards investors, internal auditors and regulatory authorities. Coordination of cross-functional steering committees and engineering teams in international projects.
Medical Software Compliance
Knowledge of medical software compliance according to EU-MDR, ISO 13485 and IEC 62304. Support for regulatory readiness and clinical compliance in the SaaS environment.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2022
Sprachen
DeutschverhandlungssicherEnglischverhandlungssicher
Projekthistorie
Leitung des QS-Rahmenwerks ueber die gesamte SDLC-Implementierung regressionsbasierter Testframeworks im Einklang mit GxP und ISO-Standards. Konzeption eines Quality Governance Frameworks mit Design Controls und RTM. Aufbau von CI-Qualitaetsmonitoring-Programmen zur Automatisierung von Test Pipelines in Jira, Confluence, Azure und Git. Mitwirkung an ISO/IEC-27001 Audits.
Etablierung und Weiterentwicklung von Softwareentwicklungsstandards ueber Azure und Jira. Entwicklung von Teststrategien und QS-Frameworks. Begleitung der Applikationsmigration von On-Premises in Cloud-Dienste und SAP CALM. Segmentierung von Penetrationstest-Protokollen und Debugging. Begleitung von UAT, Traceability-Dokumentation und RTM mit dem Product Owner.
Applikationssupport fuer SAP-Module MM, SD und PS. Migration interner Datenbestaende von CRADIS nach SAP BI und Validierung mit HP ALM und SAP CALM. Steuerung von Incidents, Service Requests und Problemloesungen. Validierung und Verifizierung von SAP-Prozessen sowie Steuerung des vollstaendigen SDLC und der Applikation Release Notes.