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Director of Regulatory Affairs: Implantable Medical Devices & AI/ML

BioTalent Ltd

BioTalent Ltd in San Diego is seeking a Senior Director of Regulatory Affairs to lead regulatory strategy for a Class III implantable platform spanning software, firmware and hardware. You will own IDE/PMA submissions and guide cross-functional teams to ensure regulatory readiness across the product lifecycle. The role requires deep FDA knowledge, experience with AI/ML-enabled features, and a track record of managing complex regulatory programs from concept through submissions and #J-18808-Ljbffr BioTalent Ltd

Vacancy posted 4 days ago
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