Senior Regulatory Affairs Lead - SaMD/MedTech (Remote)
OrganOx Limited
Madison, NJ
- Remote job
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-Ljbffr OrganOx Limited
Vacancy posted 7 hours ago
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