Minimum 8 years of directly relevant Regulatory Affairs experience in the medical device industry, including hands-on authorship, review, or leadership of regulatory submissions such as 510(k)s, Technical Documentation/Technical Files, pre-submissions, international registrations, or related applications. Partners with senior business, R&D, Clinical, Quality, Marketing, and Operations leaders to anticipate regulatory risks, influence product and portfolio decisions, and build a high-performing regulatory affairs team aligned to business objectives and applicable global requirements.