Experience

Essange Reagents

• Netherlands
• Hospitals and Health Care
• 1 - 100 Employee

• Regulatory Affairs Officer

  • Apr 2023 - Present



Pronova Laboratories

• Netherlands
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance/Regulatory Affairs manager

  • Feb 2022 - Apr 2023



Kiwa CMR

• Netherlands
• Food and Beverage Services
• 100 - 200 Employee

• QA Officer

  • Sep 2021 - Feb 2022



Leica Biosystems

• Germany
• Medical Device
• 700 & Above Employee

• Marketing Specialist, Documentation and ISH registration

  • Feb 2021 - Sep 2021

  Responsible for:• Optimization of the F4U process. • Optimization according to IVDR and ownership of the discontinuation process.Optimization according to the IVDR/ ownership of the post-market process.• Making of labels, IfU, Review of DMR’s• Making of SDS’s. • Making of marketing materials, flyers, brochures etc. • Setting up of a translate process/electronic IfU + overseeing the translations of documents. • Project lead for registration of products (Product Managers point of view). • Responsible for /giving support to Regulatory Affairs team for the registration of products in several countries.• Keeping the website up to date• Keeping contact with several external departments and vendors• Supporting the Product Managers and QA (during audits).•Execute change controle and NCR Show less

• Technical Documentation Specialist - IVDR

  • Feb 2020 - Feb 2021

  Member of the RA team, responsibilities:-Support transition to EU IVDR.-Create a process and generate quality procedures and work instructions for compiling,updating and maintaining Technical Documentation (TD), also known as Technical Files.-Create TD compliant to EU IVDR.-Support the generation of Performance Evaluation Plans and Reports.-Ensure good interface of TD process with other Quality Management System (QMS) processes, while maintaining compliance with applicable regulatory requirements.-Review/update other QMS procedures for compliance with applicable regulatory requirements including EU IVDR.-Execute change control, NCR and CAPA-Review of labeling, including Instructions for Use for compliance to applicable regulations.- Support Regulatory Affairs activities covering submissions and registrations of TD with the Notified Body.-Support audits - Ensure TD is created in a way suitable for submission to EU IVDR Eudamed Database.-Ownership of the SDS procedure. Show less

• Marketing Specialist, Documentation and ISH registration

  • Sep 2016 - Feb 2020

  Responsible for:• Optimization of the F4U process. • Optimization / ownership of the discontinuation process.• Making of labels, manuals, user guides. Review of DMR’s• Making of SDS’s. • Making of marketing materials, flyers, brochures etc. • Setting up of a translate process + overseeing the translations of documents. • Project lead for registration of products (Product Managers point of view). • Responsible for /giving support to Regulatory Affairs team for the registration of products in several countries.• Keeping the website up to date• Keeping contact with several external departments and vendors• Supporting the Product Managers and QA (during audits).•Execute change controle and NCR Show less

• Technical Documentation Officer Marketing

  • Nov 2014 - Sep 2016

  Responsible for :• Making labels and manuals according CLP/ GHS rules • Making of SDS’s • Setting up of a translate process + translation of documents. • Keeping the website up to date• Project lead of several products (exam) labeling project • Keeping contact with several external departments and vendors • Supporting the Product Managers and if needed QA



VU medisch centrum

• Amsterdam en omgeving, Nederland

• stagaire op de afdeling anatomie en neurowetenschappen

  • Nov 2013 - Jun 2014

  Verschillende werkzaamheden waaronder: *Geassisteerd met opzetten en zelfstandig uitvoeren van gedragstesten. ( nicotine & alcohol zelf- administratie). * intercraniaal infuseren (met virus) * Canuleren vena jugularis. * Verzorging huisvesting, * Correct resultaten opschrijven (welzijnsdagboek etc.) * Injecties geven (subcutaan en IP) Verschillende werkzaamheden waaronder: *Geassisteerd met opzetten en zelfstandig uitvoeren van gedragstesten. ( nicotine & alcohol zelf- administratie). * intercraniaal infuseren (met virus) * Canuleren vena jugularis. * Verzorging huisvesting, * Correct resultaten opschrijven (welzijnsdagboek etc.) * Injecties geven (subcutaan en IP)



Erasmus MC

• Rotterdam en omgeving, Nederland

• stagaire op de afdeling Nucleaire Geneeskunde

  • Sep 2010 - Jun 2011

  Verschillende werkzaamheden waaronder: * Radionuclides labellen aan peptiden op verschillende manieren o.a. beads, tubes en Chloramide T * Stabiliteit meten m.b.v. HPLC * Opzuiveren m.b.v. HPLC * Bijhouden labjournaal en maken klein rapport. Verschillende werkzaamheden waaronder: * Radionuclides labellen aan peptiden op verschillende manieren o.a. beads, tubes en Chloramide T * Stabiliteit meten m.b.v. HPLC * Opzuiveren m.b.v. HPLC * Bijhouden labjournaal en maken klein rapport.