Alexander Müller-Regulatory Affairs & Cyber Security Consultant
Check rate
Experience
Regulatory Affairs & Cyber Security Consultant
Sepp.med GmbH
- Technical lead of cyber security and regulatory projects
- Preparation of the environment and quality management system
- Preparation of EU (MDR) and FDA (USA) submissions
- Market and regulatory research
- Communication with notified bodies and authorities
- Clinical evaluation and borderline medical devices
- Cyber security: threat modeling and penetration testing
- Speaker at congresses and trade fairs
- Negotiation with customers, notified bodies, and project participants
- Team leadership and cross-functional teamwork
Consultant Medical Devices (Regulatory Affairs)
Johner-Institut GmbH
- Preparation of technical documentation EU (MDR)
- Research of international regulations
- Focus: substance-based and borderline devices
- General consulting on EU (MDR)/US (FDA) aspects
Regulatory Affairs Manager
Sepp.med Leovet Dr. Jackoby GmbH
- Managing regulatory operations for animal feed, cosmetics, biocides, and medical devices
- Support for submissions and risk management for biocides
- Involvement in technical documentation, quality management, labeling, and license maintenance
Chemical Lab Technician
Sanofi
Laboratory Worker
CSL Behring GmbH
Chemical Lab Technician
Exide
Chemi-/Biological Lab Technician
Siemens Healthineers
Industry experience
See where this freelancer has spent most of their professional time.
Experienced in Healthcare, Pharmaceutical, Cosmetics, Chemical, and Biotechnology.
Business area experience
See which departments and functions this freelancer has contributed to most.
Experienced in Quality Assurance, Information Technology, Project Management, Research and Development, and Legal.
Skills
- 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-Functional Teamwork
- Cyber Security: Threat Modeling And Penetration Testing
- Speaking At Congresses And Trade Fairs
- Communication / Nb
- Qa / Qm
- Teamwork (Crossf), Leading
- Negotiation, Project Management
- Training, Sharing Information
- Software / Cyber Security
- Technical Documentation
Languages
Education
THM in Gießen
M.Sc. Digital Medicine, Focus on „Submission (FDA/ EU)/ Rule 21/ TD “ · Digital Medicine · Giessen, Germany
THM in Gießen
B.Sc. Medical Management, Focus: Social Assurance management · Medical Management · Giessen, Germany
Käthe-Kollwitz-Schule
University entrance qualification · Marburg, Germany
Certifications & licenses
Certified Prof. For Med Software
Sepp.med Regulatory Affairs Manager
A4Q Cyber Security Essentials
Sepp.med
Certified Prof. For Project Management
Sepp.med Leovet Dr. Jackoby GmbH
Certified TesterFoundation Level
Sepp.med
Quality Management Assistent
QMF/ TÜV-Süd
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
Johner-Institut
Seminar: Udi
Johner-Institut
Statistics
Experience
Expertise
Qualifications
Profile
Frequently asked questions
Have questions? Find more information here.
Alexander is based in Leipzig, Germany.
Alexander speaks the following languages: German (Native), English (Advanced).
Alexander has at least 6 years of experience. During this time, Alexander has worked in at least 6 different roles and for 7 different companies. The average length of individual experience is 1 year and 9 months. Note that Alexander may not have shared all experience and actually has more experience.
Based on recent experience, Alexander would be well-suited for roles such as: Regulatory Affairs & Cyber Security Consultant, Consultant Medical Devices (Regulatory Affairs), Regulatory Affairs Manager.
Alexander's most recent position is Regulatory Affairs & Cyber Security Consultant at Sepp.med GmbH.
In recent years, Alexander has worked for Sepp.med GmbH, Johner-Institut GmbH, and Sepp.med Leovet Dr. Jackoby GmbH.
Alexander is most experienced in industries like Healthcare, Pharmaceutical, and Cosmetics. Alexander also has some experience in Chemical, Biotechnology, and Manufacturing.
Alexander is most experienced in business areas like Quality Assurance, Information Technology, and Project Management. Alexander also has some experience in Research and Development and Legal.
Alexander has recently worked in industries like Healthcare, Cosmetics, and Chemical.
Alexander has recently worked in business areas like Quality Assurance, Information Technology, and Project Management.
Alexander holds a Master in Digital Medicine from THM in Gießen and a Bachelor in Medical Management from THM in Gießen.
Alexander has 12 certificates. Among them, these include: Certified Prof. For Med Software, A4Q Cyber Security Essentials, and Certified Prof. For Project Management.
The availability of Alexander needs to be confirmed.
Daily rate distribution
The rates shown represent the typical market range for freelancers in this position based on recent contracts on our platform.
Average rates for similar positions
Rates are based on recent contracts and do not include FRATCH margin.
The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Calculated based on our freelancers’ daily rates as of 7 Sep 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
Similar freelancers
Discover other experts with similar qualifications and experience
Andreas Seidl
Jürgen Hertweck
Alexander Sänn
Thomas Arends
Manuel Kathofer
Juergen Mehring
Peter Sperber
Federico Leefhelm
Friederike Balaz
Markus Marschollek
Experts recently working on similar projects
Freelancers with hands-on experience in comparable project as a Regulatory Affairs & Cyber Security Consultant
Andreas Seidl
Pierre Gronau
Mike Barthel
Nikolaus Betzler
Christian Decker
Andreas Rühl
Andreas Fischer
Björn Bausch
Henry Hanau
Wilhelm Haupt
Nearby freelancers
Professionals working in or nearby Leipzig, Germany
Michael Hohlfeld
Ole Himmel
Thomas Polanski
Tilo Höde
Karl-Heinz Reis
Diana Höhne
Sebastian Pauer
Milton Bozoky
Natascha Fadeeva-Gladbach
Néstor López De Arróyabe
