Senior Regulatory Affairs Specialist

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Regulatory Affairs Specialist based in United States. This is a high-impact regulatory role supporting the development and global expansion of innovative medical devices and digital health technologies.You will help shape regulatory strategy for AI-powered software, connected hardware, and clinical technologies used by healthcare professionals worldwide.The role combines regulatory remediation, quality systems, global market access, and cross-functional product support.You will work closely with engineering, clinical, quality, and commercial teams throughout hardware and software development.Your expertise will help ensure products meet evolving regulatory requirements while supporting efficient international expansion.This is an opportunity to contribute to technologies designed to improve the detection and management of cardiovascular and pulmonary conditions.The position is ideal for an experienced regulatory professional who thrives in a fast-paced, innovation-driven environment.