Senior Manager Regulatory Affairs Medtech
Sara Ramió-Pujol, PhD, is a seasoned expert in the development and regulatory affairs of medical devices and in vitro diagnostics, with a focus on European Medicines Agency and Food & Drug Administration submissions.
During her career, Sara has played a crucial role in ensuring companies’ compliance with ISO13485:2016 quality management systems and ISO14971:2019 risk management standards. Sara also made significant contributions to developing technical documentation in line with the IVDR (EU) 2017/746 and gained valuable experience in software as a medical device development under IEC62304:2006.
Before joining Alira Health, Sara served as Technical Manager at GoodGut SLU, where she led the R&D and Manufacturing departments for various in vitro devices.
Sara’s academic contributions are extensive, including numerous peer-reviewed publications and conference presentations. She has also been invited to speak at national and international conferences and has engaged in international research collaborations.
