Hajnalka Hejja, MD
About Hajnalka Hejja, MD
Hajnalka Hejja, MD, is the Head of Surveillance & Clinical Affairs at Clue by Biowink and an Independent Evaluator for the European Commission.
Head of Surveillance and Clinical Affairs at Clue by Biowink
Since 2022, Hajnalka Hejja, MD, has been serving as the Head of Surveillance & Clinical Affairs at Clue by Biowink in Berlin, Germany. In this role, she is primarily responsible for overseeing surveillance and clinical affairs. This includes tasks such as leading the self-certification process of the Clue app under EU MDR, focusing on technical and clinical documentation, and creating a post-market surveillance system. She also manages complaints and trend analysis in compliance with both EU and FDA regulations.
Past Positions at Clue by Biowink
Before assuming her current role, Hajnalka Hejja, MD, held several other key positions at Clue by Biowink. From 2021 to 2022, she served as the Senior Medical Safety Lead, responsible for medical safety operations. Prior to this, she was the Science Lead for Product from 2020 to 2021. During her tenure, she contributed significantly to research and product-oriented partnerships with biopharmaceutical companies and was the interim lead of the Quality & Regulatory department.
CEO and Founder of Super Izzy AI
From 2016 to 2021, Hajnalka Hejja, MD, was the CEO and Founder of Super Izzy AI in the Berlin Area, Germany. In this capacity, she led the company's strategic direction and operations. Her role involved overseeing various aspects of the business, from product development to market strategy.
Medical and Clinical Experience
Hajnalka Hejja, MD, possesses extensive experience in the medical field. She worked at Tata Consultancy Services - AstraZeneca from 2013 to 2015 in Budapest, Hungary, where she held roles such as Medical Advisor, Medical Reviewer, and Lead Physician for Medical Review - Infection. She was involved in medical reviews and training during her time there. Additionally, she worked as the Marketing Manager at Omixon Biocomputing from 2012 to 2013.
Education and Research at Semmelweis University
Hajnalka Hejja, MD, completed her education at Semmelweis University. She earned her Doctor of Medicine (MD) degree from 2006 to 2012. She also participated in the Bioentrepreneur Program, achieving a Clinical Biotechnology qualification from 2012 to 2013. From 2013 to 2016, she pursued her PhD studies focused on Oxidative Stress in Preeclampsia. Her academic background provides her with a solid foundation in both general and specialized medical knowledge.
Independent Evaluator for the European Commission
Since 2015, Hajnalka Hejja, MD, has been working as an Independent Evaluator for the European Commission in the Brussels Area, Belgium. In this role, she is responsible for evaluating various projects and initiatives, utilizing her extensive medical and scientific expertise.