User Stats
| Level: | Guru |
| Member Since: | 21/10/2021 |
Profile Information
| First name | Mercè |
| Last name | Guerra |
Biotech, Diagnostics, Digital Health, Medical Device, Therapeutics, Wearables
Mercè has three and a half years of experience in Regulatory Affairs consultancy in the EU and US by working at different consultancies firms. Currently she holds the position of Regulatory Associate consultant at Alira Health.
Mercè has been part of the Medical Devices and In Vitro Diagnostics teams, being involved in the development and regulatory activities for Medical Devices/In Vitro Diagnostics, including product classification, technical documentation preparation, MDR/IVDR transition, among others.
Additionally, Mercè has been involved in drug development and regulatory activities related with EMA, FDA, and other National Competent Authorities in Europe. She has experience in orphan drugs designations, expedited programs, scientific advice, pediatric investigational plans.
Mercè holds a bachelor’s degree in Human Biology and a Master’s Degree in in Pharmaceutical and Biotechnological Industry from Pompeu Fabra University. She has been previously involved in laboratory activities related to integrated pharmacology as well as muscle biochemistry
