Senior Regulatory Affairs Lead, SaMD & Medical Devices
Listed on 2026-10-06
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Healthcare
Healthcare Compliance, Medical Science Liaison, Medical Device Industry
Organ Ox 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%.
Join us at Organ Ox Limited as our next Senior Regulatory Affairs Lead, SaMD & Medical Devices in Boston, MA, United States.
We are looking to fill the Senior Regulatory Affairs Lead, SaMD & Medical Devices position at Organ Ox Limited in Boston, MA, United States.
The Senior Regulatory Affairs Lead, SaMD & Medical Devices role at Organ Ox Limited is now open for applications in Boston, MA, United States.
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