/    /  Dominique Monferrer
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Ms. Dominique Monferrer

Trainer


PROFILE:

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.  

PROFESSIONAL EXPERIENCE:

  • Regulatory Affairs
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.)
  • Scientific Research
06/2010 - 02/2009 Postdoctoral fellow (IBMB-CSIC, Spain). 02/2009 - 02/2004 Doctoral fellow (IBMB-CSIC, Spain).

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