About this opportunity
OrganOx Limited lists this Senior Regulatory Affairs Lead, SaMD & Medical Devices opportunity in boston, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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%.
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.