Experience

Resyca

• Netherlands
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Head of Quality and Regulatory Affairs

  • May 2021 - Present



TÜV SÜD

• Germany
• Public Safety
• 700 & Above Employee

• Process Owner Certification

  • Sep 2015 - Apr 2021

  Responsibility for the process of final review and decision, Content of certificates, Participated in the MDR and IVDR readiness and implementation project, Senior Technical Certifier (until 2018) Responsibility for the process of final review and decision, Content of certificates, Participated in the MDR and IVDR readiness and implementation project, Senior Technical Certifier (until 2018)



Vectura Group

• United Kingdom
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Associate Director Regulatory Affairs

  • Jun 2012 - Jul 2015

  Technical Documentation according MDD for inhalation devicesSupport of design and development (labeling, usability, contact to test laboratories, interpretation of safety standards, DHF) Supervision of regulatory team in GautingIn 2014 Vectura PLC aquired Activaero GmbH Technical Documentation according MDD for inhalation devicesSupport of design and development (labeling, usability, contact to test laboratories, interpretation of safety standards, DHF) Supervision of regulatory team in GautingIn 2014 Vectura PLC aquired Activaero GmbH



TÜV SÜD

• Germany
• Public Safety
• 700 & Above Employee

• Senior Technical Certifier

  • Jul 2009 - Jun 2012

  Final Review and Decision on Certificates (MDD, AIMDD, EN ISO 13485)Lead auditor (MDD, AIMDD, EN ISO 13485, CMDCAS)

• Product Specialist and Auditor

  • Jul 2006 - Jun 2009

  Review of Design Dossiers (Active Implantable Medical Devices and Cardiac Catheters)Auditor (AIMDD, MDD, EN ISO 13485, ISO 9001, CMDCAS)



Max Planck Institute of Biochemistry

• Germany
• Research Services
• 200 - 300 Employee

• PHD Student / Post Doc

  • Sep 2000 - Sep 2005

  Characterization of the cell-silicon interface by methods of fluorescence microscopy Department Membrane and Neurophysics Characterization of the cell-silicon interface by methods of fluorescence microscopy Department Membrane and Neurophysics