About this opportunity
OrganOx Limited lists this Senior Regulatory Affairs Lead - SaMD/MedTech (Remote) opportunity in madison, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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
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Worksite address
madison, NJ, 07940, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.