Senior Regulatory Affairs Specialist at Route 92 Medical

Route 92 Medical is hiring a Senior Regulatory Affairs Specialist to independently manage international medical device regulatory submissions, registrations, amendments, renewals, and lifecycle activities across the United Kingdom, Japan, Latin America, and other international markets. The role includes regulatory change assessments, documentation reviews, regulatory guidance, audit support, and coordination with authorities and partners. It is onsite in San Mateo, California, or West Jordan, Utah, in a hybrid working environment, with approximately 5% travel. Candidates need a relevant bachelor's degree and at least five years of progressively responsible medical device regulatory affairs experience, including hands-on experience in the United Kingdom, Latin America, and Japan.