Profilbild von Alexander Mueller Regulatory Affairs Consultant/ Manager aus Giessen

Alexander Müller

nicht verfügbar bis 01.07.2024

Letztes Update: 25.03.2024

Regulatory Affairs Consultant/ Manager

Firma: --
Abschluss: M.Sc. Digital Medicine / Regulatory Affairs Management
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher)

Schlagwörter

Klinische Arbeiten Iso 13485 ISO 14971 Qualitätsmanagement Technische Dokumentation Medizinsches Material Regulatory Affairs Risikomanagement

Dateianlagen

Bewerbungs-Flyer_090223.pdf
Application-Alexander-Muller-S_231223.pdf

Skills

Employ me for
  • Quality Management ISO 13485
  • Technical documentation MDR
  • Market acces strategie
  • Maintaining licenses
  • RA Frameworks
  • Expert Opinions
  • Market and regulation ressearch 
  • Qualification / Classification 
  • Substance based medical devices
  • Communication with NB
basic skills/ first experience in
  • Risk management ISO 14971
  • Software as Medical Device ISO 62304
  • Submission USA FDA 510k
  • Clinical evaluation 
 
     
 
 

Projekthistorie

04/2023 - bis jetzt
Regulatory Affairs Consultant (Medical Devices)
Johner-Institut (Pharma und Medizintechnik, 50-250 Mitarbeiter)

Preparation of technical documentation EU (MDR)
Research international regulations
Fokus: Substance based and borderline devices
Consult generaly in EU (MDR)/ US (FDA) aspects
expert opinions: classification and qualification

07/2022 - bis jetzt
Regulatory Affairs Manager
Leovet Dr. Jacoby GmbH&Co.KG (Pharma und Medizintechnik, 50-250 Mitarbeiter)

  • Administration and participation of regulatory operations for animal feed, cosmetics, Biocides, and medical devices.
  • Responsible for regulatory compliance of the entire product portfolio with over 60 products distributet in 27 countries.
  • Regulatory support of stratetic projects, submissions, QA/ QC, registrations of products, as well as communication with consultants and authorities worldwide.
  • Switching individualy betwen administrative and operative role according daily updates.
Specific Operations
Submision and notification of national registration for biocides according REACH/ Biocide regulation
Consulting in medical device strategy
Participation and review of technical documentation
Participating in Quality management
Label proff in legal aspects
Implementation of Triman-Logo
Registration of Feed in USA, Newsealand, and EU
Rescue Exports from border control

10/2016 - 03/2017
Chemical Lab Technician
Sofotec/ Astra Zeneca (Pharma und Medizintechnik, 500-1000 Mitarbeiter)

Research and Development,
Device-Development
GMP compliant Lab assistence

02/2016 - 09/2016
Chemical Lab Technician
Sanofi (Pharma und Medizintechnik)

Quality Controll for Package

11/2015 - 02/2016
Laboratory Worker
CSL Behring GmbH


09/2015 - 10/2015
Chemical Lab Technician
Exide

Research and Development in physical Lab

05/2015 - 09/2015
Lab Technician
Siemens Healthineers (Pharma und Medizintechnik, 250-500 Mitarbeiter)

Lab Assistent/ Complaint Handling
GMP compliant Lab assistence

Zertifikate

QMB
Tüv-Süd
2022
Quality Management Assistend
TÜV-Süd
2022

Reisebereitschaft

Nur Remote verfügbar

Sonstige Angaben

Dear Medical Device Manufacturer, Consultant or Relative:

Im happy to tell you that if you need support in regulatory issues for
medical devices and your company is remotly accessable...

... It would be a pleassure for me to participate your company and
everything behind

Quality Management ISO 13485
Risk Management ISO 14971
Technical documentation
Marked acces strategie
Maintaining licenses
RA Frameworks
Profilbild von Alexander Mueller Regulatory Affairs Consultant/ Manager aus Giessen Regulatory Affairs Consultant/ Manager
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