Principal 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 Principal Regulatory Affairs Specialist based in United States. This is a senior regulatory affairs opportunity supporting the development, registration, and lifecycle management of medical device products across global markets. The role combines regulatory strategy, submission leadership, compliance, and commercial support across complex product portfolios. You will help shape regulatory approaches for new and modified products while ensuring requirements are embedded throughout the product lifecycle. Working across U.S., European, and international frameworks, you will influence market access and help navigate evolving regulatory expectations. The position offers significant autonomy, with responsibility for multiple projects and the opportunity to identify and resolve regulatory risks proactively. You will collaborate closely with cross-functional, regional, and global stakeholders in a technically sophisticated healthcare environment. This is an impactful role for an experienced regulatory professional who enjoys solving complex problems and accelerating compliant product access.