Senior Regulatory Affairs Lead - SaMD/MedTech (Remote)
OrganOx Limited
OrganOx Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America, including FDA activities for SaMD/SiMD and electromechanical devices. The role requires collaborating with Manufacturing, Quality, R&D, and Marketing to ensure compliance with ISO, GMP, and medical device standards.
The position offers flexible remote or hybrid on-site work in Madison, NJ with travel up to 5% domestically or internationally, and reports to the Director of
#J-18808-LjbffrVacancy posted 10 hours ago
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