Marc Bergenthal

Angestellt, Manager Regulatory Affairs, Brainlab

Abschluss: Bachelor of Science, FernUniversitaet in Hagen

Unterschleißheim, Deutschland

Fähigkeiten und Kenntnisse

Regulatory Affairs
FDA Regulation
Quality Management
Medical Devices
ISO 13485
ISO 14971
IEC 62304
Software
Medical Monitoring Devices
Verification and validation
Vorstellungsgespräch
Softwareentwicklung

Werdegang

Berufserfahrung von Marc Bergenthal

  • Bis heute 2 Jahre und 5 Monate, seit Jan. 2022

    Manager Regulatory Affairs

    Brainlab
  • Bis heute 3 Jahre und 5 Monate, seit Jan. 2021

    Consultant and Freelancer

    Bergenthal Consulting
  • 2 Jahre, Jan. 2020 - Dez. 2021

    Manager Regulatory Affairs

    Philips GmbH
  • 1 Jahr und 2 Monate, Nov. 2018 - Dez. 2019

    Teamleader QM

    Getinge
  • 1 Jahr und 8 Monate, März 2017 - Okt. 2018

    Regulatory Affairs Specialist

    Getinge
  • 10 Monate, Mai 2016 - Feb. 2017

    QM Consultant - Regulatory Affairs

    Brainlab

    - Review of Technical Files / Design Dossiers before CE marking a new/changed product - Evaluate product design changes and accompany their implementation - Compile regulatory submissions e.g. 510(k) submissions to FDA, Europa, Singapore and Middle East - Monitor and investigate regulatory requirements for defined countries - Train employees in regulatory requirements - Plan and perform internal audits - Process owner for standards management

  • 2 Jahre und 1 Monat, Apr. 2014 - Apr. 2016

    QM Associate - Regulatory Affairs

    Brainlab
  • 9 Monate, Juli 2013 - März 2014

    QM Assistant - Regulatory Affairs

    Brainlab
  • 1 Jahr und 10 Monate, Sep. 2011 - Juni 2013

    Industrial Trade Apprentice

    Brainlab
  • 1 Jahr und 10 Monate, Sep. 2009 - Juni 2011

    Deputy Head of Service (stellvertretender Dienststellenleiter)

    Bundeswehr

    - Performed disciplinary investigations and interviews - Performed appraisal interviews on behalf of the Head of Service - Prepared, executed and evaluated trainings and presentations - Supported and planned the organization of the department - Assigned as Data Protection Commissioner and IT Commissioner for the department

  • 3 Jahre und 2 Monate, Juli 2006 - Aug. 2009

    Officer Candidate (Offizieranwärter)

    Bundeswehr

Ausbildung von Marc Bergenthal

  • 4 Jahre und 6 Monate, Okt. 2014 - März 2019

    Economic Science (Wirtschaftswissenschaften)

    FernUniversitaet in Hagen

    Relevant courses included: Principles of Economic Mathematics and Statistics, Introduction to Business Informatics, Investment and Financing, Theory of Market Economy, Management, Instruments of Controlling, Modeling of information systems

  • 2 Jahre, Sep. 2007 - Aug. 2009

    Informatics (Informatik)

    Universitaet der Bundeswehr Muenchen

    Relevant courses included: Discrete Mathematics, Analysis, Linear Algebra, Electrical Engineering Fundamentals, Computer Architecture, Introduction to Programming Languages

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

Interessen

Digital Photography

21 Mio. XING Mitglieder, von A bis Z