Sr. Regulatory Affairs Specialist II

Conduct regulatory submissions to the US FDA and international authorities, including 510(k) and Q-submissions, while serving as the primary contact for agencies to negotiate data requirements. Author regulatory assessments for product changes, manage advertising and promotional materials with cross-functional partners, and maintain device listings and UDI submissions. Monitor regulatory landscape shifts, interpret guidance directives, and implement process updates. Maintain daily regulatory operations, data files, and support audits. Mentor junior staff and lead departmental training on regulatory procedures.