Alexander M.
Regulatory Affairs & Cyber Security Consultant
Experience
Mar 2024 - Present
1 year 7 monthsRegulatory Affairs & Cyber Security Consultant
Sepp.med GmbH
- Risk management ISO 14971, QMS ISO 13485, technical documentation MDR, software life-cycle IEC 62304, cyber security ISO 81001-5-1, usability ISO 62366
- Penetration testing, project management, US-FDA submission, EU-MDR submission, market and regulatory research, communication with notified bodies and authorities, clinical evaluation, borderline medical devices (cross function) teamwork, cyber security: threat modeling/pentesting
- Technical leading of cyber security and regulatory projects
- Speaker at congresses and trade fairs
Apr 2023 - Present
2 years 6 monthsConsultant Medical Devices (Regulatory Affairs)
Johner-Institut GmbH
- Preparation of technical documentation EU (MDR)
- Research international regulations
- Focus: substance based and borderline devices
- Consult generally in EU (MDR) and US (FDA) aspects
Jul 2022 - Mar 2023
9 monthsRegulatory Affairs Manager
Sepp.med Leovet Dr. Jackoby GmbH
- Administrating regulatory operations for animal feed, cosmetics, biocides, and medical devices
- Support for submissions and risk management for biocides including worldwide correspondence
- Participating in technical documentation, quality management, labeling, and maintaining licenses for medical devices (Class I)
Oct 2016 - Mar 2017
6 monthsChemical Lab Technician
Sofotec / Astra Zeneca
Feb 2016 - Sep 2016
8 monthsChemical Lab Technician
Sanofi
Nov 2015 - Feb 2016
4 monthsLaboratory Worker
CSL Behring GmbH
Sep 2015 - Oct 2015
2 monthsChemical Lab Technician
Exide
May 2015 - Sep 2015
5 monthsChemi- / Biological Lab Technician
Siemens Healthineers
Languages
German
NativeEnglish
AdvancedEducation
Apr 2022 - Mar 2024
Technische Hochschule Mittelhessen in Gießen
M.Sc. · Digital Medicine · Germany
Oct 2018 - Mar 2022
Technische Hochschule Mittelhessen in Gießen
B.Sc. · Medical Management · Germany
Jul 2017 - Jun 2018
Käthe-Kollwitz-Schule in Marburg
Vocational high school diploma · Germany
...and 1 more
Certifications & licenses
Certified Professional for Medical Software
Sepp.med Regulatory Affairs Manager
A4Q Cyber Security Essentials
Sepp.med
Certified Professional for Project Management
Sepp.med Leovet Dr. Jackoby GmbH
Certified Tester Foundation Level
Sepp.med
Quality Management Assistant
QMF/ TÜV-Süd
Quality Management Specialist
QMB/ TÜV-Süd
Seminar: Clinical Evaluation
Johner-Institut
Seminar: Medical Device Regulation
Johner-Institut
Seminar: Medical Software ISO 62304
Johner-Institut
Seminar: Requirements US-FDA
Johner-Institut
Seminar: Risk Management ISO 14971
Johner-Institut
Seminar: UDI
Johner-Institut
Need a freelancer? Find your match in seconds.
Try FRATCH GPT More actions
Similar Freelancers
Discover other experts with similar qualifications and experience
- English
- Deutsch
2025 © FRATCH.IO GmbH. All rights reserved.