Regulatory Device Specialist

Prepare and submit high-quality routine regulatory submissions to the FDA and other global health authorities within company timelines. Review, interpret, and communicate domestic and foreign regulations to ensure complete and scientifically sound product submissions. Manage international product registrations, license renewals, and amendments across markets including EU, APAC, Middle East, and Latin America. Support regulatory compliance through customer complaints, internal audits, and training systems while assisting in updating internal policies. Coordinate export documentation, notarization, and consularization for foreign governments. Assess new market opportunities by determining device classification, registration pathways, and submission content for product launches. Review labeling, Instructions for Use, and promotional materials for country-specific content and UDI requirements. Support Notified Body, MDSAP, and international regulatory inspections, including preparation of requested documentation and follow-up on findings. Monitor evolving global regulations and communicate required actions to cross-functional stakeholders.