Catarina Pinho

Catarina Pinho is a Regulatory Specialist at Boule Diagnostics AB, responsible for preparing technical documentation for global product registration while working within a Quality Management System aligned with ISO13485 and 21 CFR 820. Prior experience includes serving as a Quality Assurance & Regulatory Affairs Specialist and Regulatory Affairs Specialist at FindOut Diagnostic AB, where Catarina led Design Reviews for IVDD/IVDR compliance, managed risk assessments, and communicated with regulatory authorities for market approvals. At Calmark Sweden AB, Catarina held roles as Project Manager and Product Developer, focusing on product development and compliance with in vitro diagnostics regulations. Catarina possesses a strong research background with postdoctoral fellowships at Karolinska Institutet and Stockholm University, complemented by a Bachelor's degree in Biochemistry from Universidade do Porto.