Regulatory affairs professional with more than 9 years experience in development, approval and post-approval of medical devices (MDs) / in vitro diagnostics (IVDs), and pharmaceutical products (chemical drugs, biologics - biosimilars, ATMPs and herbal medicinal products). Experience based on numerous consultancy projects for pharma, biotech and medtech companies.
Expert in EU regulations of MDs/IVDs of a wide technological diversity (i.e. wound-care, vascular, implant/orthopedic, substance-based and drug/device combinations, among others).
Profound understanding of CE marking requirements under MDD/IVDD and MDR/IVDR legal frameworks, and of relevant regulatory guidelines and technical standards (including MEDDEV, IMDRF/GHTF and ISO/IEC/EN/ASTM/CLSI, etc.).
Good knowledge of FDA regulations for MDs and IVDs.
Leader of the medical devices team of the company since 2015, currently responsible for 6 direct reports.
11/2015 - Present Scientific & Regulatory Affairs Associate Director (Asphalion S.L.)
03/2013 - 10/2015 Regulatory Affairs Manager (Asphalion S.L.)
03/2012 - 03/2013 Senior Regulatory Affairs Officer (Asphalion S.L.)
03/2011 - 03/2012 Regulatory Affairs Officer (Asphalion S.L.)
R&D Funds and Technology Survey
10/2010 - 03/2011 Innovation Officer (Intelligent Pharma S.L.)
06/2010 - 02/2009 Postdoctoral fellow (IBMB-CSIC, Spain).
02/2009 - 02/2004 Doctoral fellow (IBMB-CSIC, Spain).