Ursina Haltinner

Ursina Haltinner has over 10 years of experience in Regulatory Affairs. Ursina began their career in 2008 as a Regulatory Affairs Specialist at Synthes GmbH. In 2013, they moved to CSL Behring AG as a Regulatory Affairs Manager and CMC Biologics. In 2016, they joined Novartis Pharma Schweiz as a Regulatory Affairs Coordinator. In 2018, they were appointed as Head of Regulatory and Quality Affairs and Regulatory and Quality Affairs Manager at hemotune AG.

Ursina Haltinner obtained their Dr. med. vet. degree in Veterinärmedizin from the University of Zurich in 2005. Ursina has also obtained several certifications and bescheinigungen from TÜV SÜD, including a Zertifikat_Auditor für Qualitätsmanagement in der Medizinprodukteindustrie nach ISO 13485:2016 - TÜV in 2021, a Zertifikat_Beauftragter für Qualitätsmanagement in der Medizinprodukteindustrie nach ISO 13485:2016 in 2020, a Zertifikat_Fachkraft für Qualitätsmanagement in der Medizinprodukteindustrie nach ISO 13485:2016 in 2019, a Zertifikat_Manager Regulatory Affairs - TÜV in 2009, a Zertifikat_Specialist Managementsystems - TÜV in 2009, a Bescheinigung_Klinische Bewertung von Medizinprodukten in 2008, a Bescheinigung_Risikomanagement und Risikoanalyse für Medizinprodukte in 2008, and a Zertifikat_Specialist Technical Documentation - TÜV in 2008.