Recommended expert

Alexander Müller

Regulatory Affairs & Cyber Security Consultant

Alexander Müller
Leipzig, Germany

Experience

Mar 2024 - Present
1 year 11 months

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
2 years 10 months

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

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

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