Agatha Szeliga

Agatha Szeliga is a seasoned professional in regulatory affairs, currently serving as the Director of Regulatory Affairs at Clarius Mobile Health since March 2021. Szeliga has successfully led multiple regulatory initiatives, including achieving EU MDR certification and 510(k) clearance for new medical devices, while ensuring compliance with ISO standards and managing QMS improvements. Prior experience includes serving as Regulatory Affairs Manager at Stryker, where seven 510(k) clearances were obtained in a two-year period, and as Regulatory Affairs Manager at NOVADAQ, overseeing pre-market submissions across various jurisdictions. Szeliga's expertise extends to comprehensive regulatory strategy development, interaction with regulatory agencies, and management of compliance-related documentation. An educational background includes a degree from the University of Toronto, supplemented by studies at Seneca Polytechnic and TIPT.