Freelancer profile translated to English.
Back to original languageAbout Alexander
I advise manufacturers on approval according to EU MDR, US FDA, and the application of harmonized standards such as ISO 13485 (QMS) and ISO 14971 (Risk Management). I support them in creating technical documentation, validation (V&V), and preparation for Notified Bodies – structured, traceable, and audit-proof.
In the area of software development (SaMD) and cybersecurity, I guide projects according to IEC 62304 and conduct penetration tests and security assessments on KALI Linux. My focus is on the security lifecycle according to IEC 81001-5-1, as well as compliance with NIS-2 and the Cyber Resilience Act (CRA). This results in secure, standards-compliant, and sustainable SaMD products with secure IT infrastructure. My management skills include agile team leadership, AI-supported process automation, and coordination with and within cross-functional teams. I support companies in communicating with Notified Bodies and integrating digital compliance workflows for greater efficiency and transparency.
Feel free to ask if you want to master your compliance with me.
German
Native or bilingual
English
Fluent
Can work on-site
Gießen (up to 50km), Frankfurt am Main (up to 50km), Koblenz (up to 50km)
Experience
- Altona DiagnosticsRegulatory Affairs & Cybersecurity ManagerBIOTECHMarch 2026 - June 2026 (3 months)Hamburg, GermanyDevelopment of IVDR Medical DevicesEnsuring Software- and Security Development lifecyclePrepare Technical DocumentationProduct registration in EU, US (FDA) and MDSAP CountriesDevelopment of AI driven medical SoftwarePreparing Software Development KIT (SDK) for Development of Software as Medical Devices (IVD) (SaMD)
- Sepp.medRegulatory Affairs & Cybersecurity ConsultantCONSULTING AND AUDITSApril 2024 - February 2026 (1 year and 10 months)Erlangen, GermanyConsultancy in Future Health & Medical Device Industry.Focus on Cyber Security, AI-driven Devices & Norm-ConformityKey accountabilities: Technical Documentation, Risk management, Cyber Security ISO 81001-5-1, Submission/ Communication with NB, Software-Life-Cycle, Requirement Engineering, IT-Security, Qualification and Classification, NIS 2, Post-Market-Surveillance, Quality Management under ISO 9000, 13485 & Information security management systems (ISMS) and ISO 27001
- Johner InstitutRegulatory Affairs ConsultantCONSULTING AND AUDITSApril 2023 - March 2024 (1 year)Kostnitz, GermanyConsultancy in regulatory operations for medical devicesKey parts: international regulatory affairs and research, submissions, qualification and classification of devices, borderline and substance-based medical devices, preparation of technical documentation, communication with notified bodies.
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Education
- Digital Medicine (Regulatory Affairs)Gießen2024Regulatory Affairs für Medizinprodukte
- Bachelor B.Sc. Medical ManagementTHM Gießen2022Management in Gesundheitswesen Spezialisierung: Sozialversicherungsmanagement