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.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.