Stefanie Hirsch

Stefanie Hirsch has extensive experience in quality management, regulatory affairs, and compliance in various leadership roles. Stefanie started their career in 1996 at Roche as a Placement Student. From 2000 to 2008, they worked at Abbott Diagnostics, where they held several managerial positions, including Quality System Manager and Manager PQA, Reg. Aff., Auditing. During this time, they were responsible for managing the quality system, overseeing audits, and implementing complaint handling systems.

In 2008, they joined Ortho Clinical Diagnostics as Director of Quality & Regulatory Affairs EMEA, where they led the Quality and Regulatory Affairs team and ensured compliance with ISO standards and country regulations. Stefanie then moved on to become Senior Director of Quality & Regulatory Affairs EMEA & ASPAC, responsible for implementing quality and regulatory standards across commercial affiliates in the EMEA and ASPAC regions.

In 2018, Stefanie Hirsch joined Dräger as Vice President and later President of Quality & Regulatory Affairs. Their responsibilities included global leadership of the Quality Management System and Regulatory Affairs, as well as developing and implementing regulatory strategies. Stefanie focused on continuous improvement of the quality management system to support business strategies and ensure compliance with regulatory requirements.

Throughout their career, Stefanie Hirsch has demonstrated their expertise in quality management, regulatory affairs, and compliance, and their ability to lead global teams and develop effective strategies to ensure adherence to standards and regulations.

Stefanie Hirsch obtained a degree in Biotechnology, specifically a Dipl.-Ing. (FH), from Hochschule Mannheim between the years 1994 and 2000. Stefanie has also obtained several additional certifications, including "Big-Data-Grundlagen: Methoden und Konzepte im Zeitalter von KI" and "Strategieentwicklung: Ein Überblick" from LinkedIn, "RAPS Member" from the Regulatory Affairs Certification Program in 2017 and 2020, "Certificate in Quality Assurance (Level 3)" from the Chartered Quality Institute in 2008, and "Certified ISO 9000 QMS Auditor / Lead Auditor" from the Irish Quality Centre in 2006.