Alexandra Goncalves

Angestellt, Regulatory Affairs Manager, Mika
Berlin, Deutschland

Werdegang

Berufserfahrung von Alexandra Goncalves

  • Bis heute 1 Jahr und 10 Monate, seit Okt. 2023

    Regulatory Affairs Manager

    Mika

  • 2 Jahre, Jan. 2018 - Dez. 2019

    Quality Manager

    bess pro gmbh

  • 4 Monate, Juni 2016 - Sep. 2016

    Product Validation Engineer

    DNA Electronics

    - Conduct experiments methodically, analyse data, interpret results and form conclusions. - Developing product specifications, drawings and quality plans. - Creating and managing the Product Development Validation Plan. - Verifying and running tests on sub-system level assemblies in development.

  • 1 Jahr und 3 Monate, März 2015 - Mai 2016

    Microfluidics Engineer

    Genetics Microdevices Ltd

    - Designing and developing microfluidic Lab-on-a-Chip devices for biological analysis of proteins, DNA and small molecules, and for single cell trapping. - Manufacturing of disposable microfluidic chips using different techniques: photolithography, etching, hot embossing, CNC machine.

  • 4 Jahre und 7 Monate, Sep. 2010 - März 2015

    Quality Assurance and Regulatory Affairs Manager

    Kinematix

    - Developing and maintaining technical and non-technical documentation of medical products: product manuals, user manuals, helps of the software. - Responsible for the development, implementation and maintenance of the Quality Management System in accordance with International Standards including ISO 9001 and ISO 13485 requirements. - Managing all aspects of Regulatory Affairs including CE marking and FDA registration of the products. - Responsible for performing internal quality audits.

  • 1 Jahr, Aug. 2009 - Juli 2010

    R&D Engineer

    Biosurfit

    - Designed, modelled, prototyped and tested new centrifugal microfluidic devices for in-vitro medical diagnostic applications: Hematocrit measurement and Erythrocyte Sedimentation rate. - Designed of microfluidics devices using 3D design tools (Autodesk AutoCAD). - Prototyped Lab-on-a-disk platforms through different techniques (laser ablation, photolithography, cutting plotter, CNC machine). - Developed master thesis: "Development of a new method of clinical analysis in device Lab-on-a-disk".

  • 2 Monate, Juli 2008 - Aug. 2008

    Researcher

    Kinematix

    Developed a state-of-the-art report regarding a prototype of a new medical device to prevent pressure ulcers in bedridden patients.

Ausbildung von Alexandra Goncalves

  • 2008 - 2010

    Biomedical Sciences

    University of Beira Interior

  • 2005 - 2008

    Biomedical Sciences

    University of Beira Interior

Sprachen

  • Portugiesisch

    Muttersprache

  • Englisch

    Fließend

  • Deutsch

    Gut

  • Spanisch

    Grundlagen

XING – Das Jobs-Netzwerk

  • Über eine Million Jobs

    Entdecke mit XING genau den Job, der wirklich zu Dir passt.

  • Persönliche Job-Angebote

    Lass Dich finden von Arbeitgebern und über 20.000 Recruiter·innen.

  • 22 Mio. Mitglieder

    Knüpf neue Kontakte und erhalte Impulse für ein besseres Job-Leben.

  • Kostenlos profitieren

    Schon als Basis-Mitglied kannst Du Deine Job-Suche deutlich optimieren.

21 Mio. XING Mitglieder, von A bis Z