• Leading development and execution of global regulatory strategy in collaboration with interdisciplinary product teams in compliance with international regulatory requirements and the Quality Management System. • Preparing, submitting, and managing regulatory dossiers required for new product marketing and modified product applications in a global market. • Preparing, submitting, and managing Technical Files in compliance with the requirements of the European Union (EU IVDR). • Prepare, submit, and manage FDA marketing submissions including PMA (including Annual Reports and Supplements), 510(k) Pre-Market Notifications, and Pre-Submissions. • Acting as a Regulatory Affairs subject matter expert on new product introduction and design control teams. • Advising teams on regulatory requirements including labeling reviews, R&D and clinical study design, and design change regulatory impacts. • Participating in internal and external quality system and design dossier audits