Cecilia Tran-JørgensenQA Manager & Data Protection Officer
Cecilia Tran-Jørgensen, Regulatory Expert, joined Cercare Medical ApS in early 2017 as QA Manager. She acts as management representative in regulatory approval processes (CE marking and FDA approval) at Cercare Medical ApS. She ensures that processes related hereto, such as medical device classification, clinical evaluation, risk management, and quality management system, are implemented in compliance with current legislative texts (the Medical Device Directive for CE marking and the FDA Code of Federal Regulations, Title 21), and to prepare compliance with new legislative texts that will replace current legislation (the Medical Device Regulations for CE marking). Furthermore, she acts as Data Protection Officer in compliance with EU’s General Data Protection Regulation (GDPR).
Cecilia has a background as Health Technology Engineer, graduating from Aarhus University, and specializing in regulatory approval of medical devices. Prior to joining Cercare Medical ApS, Cecilia worked as QA Consultant and Project Manager with several companies and regions in Denmark. Cecilia has been responsible for working with the EU medical device classes I, IIa and IIb, and preparing necessary documentation for regulatory approval processes. During the past few years, Cecilia has attended numerous training courses in subjects related to regulatory approval, such as the industry standards BS EN ISO 13485:2016 for quality management systems, BS EN ISO 14971:2012 for risk management, and BS EN ISO 19011:2011 for auditing. Furthermore, she has attended DPO training in compliance with EU’s GDPR.