Senior Regulatory Affairs Specialist - Remote MedTech & SaMD

OrganOx is a global medical device company focused on organ technology. The Senior Regulatory Affairs Specialist will lead regulatory submissions for North America, support ISO/GMP compliance, and collaborate with R&D, Manufacturing and QA to advance OrganOx products. The role is flexible remote or hybrid on-site in Madison, NJ with up to 5% travel. Ideal candidates have 3–8 years in regulatory affairs for Class II/III devices and SaMD/SiMD.