Alexander Müller - Regulatory Affairs & Cyber Security Consultant

Q: Where is Alexander based?

Alexander is based in Leipzig, Germany .

Q: What languages does Alexander speak?

Alexander speaks the following languages: German (Native), English (Advanced) .

Q: How many years of experience does Alexander have?

Alexander has at least 5 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.

Q: What is Alexander's latest experience?

Alexander's most recent position is Regulatory Affairs & Cyber Security Consultant at Sepp.med GmbH .

Q: What companies has Alexander worked for in recent years?

In recent years, Alexander has worked for Sepp.med GmbH , Johner-Institut GmbH , and Sepp.med Leovet Dr. Jackoby GmbH .

Q: Which industries is Alexander most experienced in?

Alexander is most experienced in industries like Healthcare , Pharmaceutical , and Cosmetics . Alexander also has some experience in Chemical , Biotechnology , and Manufacturing .

Q: Which business areas is Alexander most experienced in?

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 .

Q: What is Alexander's education?

Alexander holds a Master in Digital Medicine from THM in Gießen and a Bachelor in Medical Management from THM in Gießen .

Q: Does Alexander have any certificates?

Alexander has 12 certificates . Among them, these include: Certified Professional for Medical Software , A4Q Cyber Security Essentials , and Certified Professional for Project Management .

Recommended expert

Leipzig, Germany

Experience

Mar 2024 - Present

2 years 1 month

Regulatory Affairs & Cyber Security Consultant

Sepp.med GmbH

Technical lead for cyber security & regulatory projects
Preparation of environment & quality management system
Preparation of EU (MDR) & 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 & project participants
Team leadership & cross-functional teamwork

Apr 2023 - Present

3 years

Consultant Medical Devices (Regulatory Affairs)

Johner-Institut GmbH

Preparation of technical documentation for EU (MDR)
Research on international regulations
Focus: substance-based and borderline devices
General consulting on EU (MDR)/US (FDA) aspects

Jul 2022 - Mar 2023

9 months

Regulatory Affairs Manager

Sepp.med Leovet Dr. Jackoby GmbH

Administering regulatory operations for animal feed, cosmetics, biocides, and medical devices
Support for submissions and risk management for biocides
Participation in technical documentation, quality management, labeling, and license maintenance

Feb 2016 - Sep 2016

8 months

Chemical Lab Technician

Sanofi

Nov 2015 - Feb 2016

4 months

Laboratory Worker

CSL Behring GmbH

Sep 2015 - Oct 2015

2 months

Chemical Lab Technician

Exide

May 2015 - Sep 2015

5 months

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.

Healthcare

Pharmaceutical

Cosmetics

Chemical

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.

Quality Assurance

Information Technology

Project Management

Research and Development

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

German

Native

English

Advanced

Education

Apr 2022 - Mar 2024

THM in Gießen

M.Sc. Digital Medicine, Focus on FDA/EU submissions, Rule 21/TD · Digital Medicine · Giessen, Germany

Oct 2018 - Mar 2022

THM in Gießen

B.Sc. Medical Management, Focus: Social security management · Medical Management · Giessen, Germany

Jul 2017 - Jun 2018

Käthe-Kollwitz-Schule

Technical high school diploma · Marburg, 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: US FDA Requirements

Johner-Institut

Seminar: Risk management ISO 14971

Johner-Institut

Seminar: UDI

Johner-Institut

Statistics

Experience

Total positions 7

Experience in Healthcare 4 y

Avg length 1 y

Longest experience 2 y 11 m

Expertise

Recent roles Regulatory Affairs & Cyber Security Consultant, Consultant Medical Devices (Regulatory Affairs), Regulatory Affairs Manager

Main industries Healthcare, Pharmaceutical, Cosmetics

Main business areas Quality Assurance, Information Technology, Project Management

Qualifications

Highest degree Master

Certifications earned 12

Profile

Created

September 2025

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Alexander based?

Alexander is based in Leipzig, Germany.

What languages does Alexander speak?

Alexander speaks the following languages: German (Native), English (Advanced).

How many years of experience does Alexander have?

Alexander has at least 5 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.

What roles would Alexander be best suited for?

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.

What is Alexander's latest experience?

Alexander's most recent position is Regulatory Affairs & Cyber Security Consultant at Sepp.med GmbH.

What companies has Alexander worked for in recent years?

In recent years, Alexander has worked for Sepp.med GmbH, Johner-Institut GmbH, and Sepp.med Leovet Dr. Jackoby GmbH.

Which industries is Alexander most experienced in?

Alexander is most experienced in industries like Healthcare, Pharmaceutical, and Cosmetics. Alexander also has some experience in Chemical, Biotechnology, and Manufacturing.

Which business areas is Alexander most experienced in?

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.

What is Alexander's education?

Alexander holds a Master in Digital Medicine from THM in Gießen and a Bachelor in Medical Management from THM in Gießen.

Does Alexander have any certificates?

Alexander has 12 certificates. Among them, these include: Certified Professional for Medical Software, A4Q Cyber Security Essentials, and Certified Professional for Project Management.

What is the availability of Alexander?

Alexander is immediately available for suitable projects.

What is the rate of Alexander?

Alexander's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.