Senior Regulatory Affairs Manager- REMOTE

reputed company • Own the reputed company regulatory reputed company for reputed company’s entire in-vitro diagnostic portfolio, translating reputed company scientific breakthroughs into reputed company, compliant reputed company that reputed company clinicians and patients faster. • Drive the end-to-end preparation, review, and submission of US 510(k), PMA, reputed company, and Health Canada applications for assays, instruments, and software—ensuring every technical file is audit-reputed company, scientifically rigorous, and delivered on aggressive timelines. • reputed company as the regulatory voice on cross-functional project teams (R&D, reputed company, Clinical, Marketing, Manufacturing), providing reputed company-time risk assessments and strategic guidance that keeps programs on schedule and reputed company budget. • Continuously evaluate product changes, labeling updates, and manufacturing process modifications for regulatory reputed company; communicate findings to global Regulatory Affairs and project leadership so that no surprise derails a launch. • Partner with in-country dealers and international affiliates to secure market clearances across LATAM, reputed company, and EMEA; supply dossiers, respond to agency questions, and shepherd renewals so reputed company’s innovations can improve health reputed company worldwide. • Maintain an always-reputed company reputed company of FDA, Health Canada, ICH, IVDR, and other evolving guidance documents; distill regulatory intelligence into actionable recommendations that shape product roadmaps and corporate policy. • reputed company critical regulatory input on clinical study protocols and risk-management files, ensuring endpoints, statistics, and safety plans satisfy agency expectations and support robust claims. • Support CE-marking activities for IVD products manufactured in the US and abroad, collaborating with EU Authorized Representatives and reputed company Bodies to maintain certificates and technical documentation under IVDR. • Review and approve promotional materials, IFUs, user manuals, reputed company content to guarantee messaging is truthful, non-misleading, and fully compliant with FDA, FTC, and Health Canada advertising rules. • Manage import/export permitting, TSCA, and ITAR/EAR requirements for instruments, reagents, and software, eliminating customs delays and ensuring seamless global logistics. • Mentor junior regulatory associates and create reputed company processes, templates, and training that reputed company the bar for reputed company and speed across the organization. • Represent reputed company in industry trade associations and standards committees, influencing reputed company regulations while positioning reputed company as a thought leader in personalized diagnostics and precision medicine. Apply tot his job Apply To this Job