OrganOx Limited seeks a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America, including FDA IDEs/PMAs and Health Canada, and to help implement quality goals. The role reports to the Director of Regulatory Affairs and collaborates with QA, Manufacturing, R&D, and Marketing as needed.
The position requires experience with SaMD/SiMD, Class II/III devices, and GMP compliance. It offers a flexible remote or hybrid work arrangement in Madison, NJ with travel up to 5%.
#J-18808-LjbffrSenior Regulatory Affairs Lead, SaMD & Medical Devices in boston at Unknown Company
This position is listed as full time and able to be worked remotely.