AusDiagnostics
Gisah Bittencourt Sad is a highly experienced Regulatory Affairs Manager at AusDiagnostics since June 2022, with previous roles including Senior Regulatory Affairs Associate and Regulatory Affairs Specialist at VESTECH and Minomic International Ltd. Gisah possesses extensive expertise in regulatory submissions, compliance, and strategic planning across various jurisdictions, including the US, EU, and AU. The professional history includes significant contributions to regulatory strategy, compliance maintenance, and implementation of relevant standards such as MDR 2017/745 and ISO 14971/2019. Educational qualifications include a Bachelor of Pharmaceutical Sciences from Universidade Federal do Paraná, alongside additional studies in Project Management, International Business, Marketing, and Leadership from various institutions.
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AusDiagnostics
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AusDiagnostics Pty Ltd is a leading international company that designs, manufactures and markets a comprehensive suite of multiplexing molecular diagnostic assays and reagents. Founded in August 2006, AusDiagnostics also supports robotic instruments for human diagnostics, animal diagnostics and applied testing. In the past five years, the company has expanded its reach to global customers through offices in New Zealand, the United Kingdom and the United States. In 2018, AusDiagnostics opened a manufacturing facility in the United Kingdom to support the supply of products to its growing network of distribution partners in more than 25 countries. AusDiagnostics continues to develop new technology, and conduct scientific research into innovative diagnostic methodologies for customers around the world.