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.