Principal Regulatory Affairs Specialist, Labeling (SWICC)

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, Labeling (SWICC) based in the United States. The Principal Regulatory Affairs Specialist will serve as the global regulatory authority for medical device labeling and Unique Device Identification (UDI) across a portfolio of surgical workflow and infection control consumables. This role ensures that product labels, packaging, instructions for use, and promotional materials comply with evolving regulatory requirements across the United States, Europe, and international markets. You will lead labeling strategies, oversee a high volume of label versions, and translate complex regulatory changes into clear actions for cross-functional teams. Working closely with R&D, Quality, Marketing, Manufacturing, and international regulatory colleagues, you will help maintain product compliance throughout the product lifecycle. You will also guide UDI data management, support regulatory submissions, and contribute to audits and quality system improvements. This is a global, highly specialized opportunity to influence regulatory excellence and help ensure the safe and effective use of medical devices worldwide.