Senior Regulatory Affairs Specialist

VirtualVocations
Chicago, Illinois, United States
Full-time

A company is looking for a Senior Regulatory Affairs Specialist, Medical Devices.Key ResponsibilitiesProvide regulatory strategic leadership for medical device products, including AI / ML-enabled devicesLead regulatory submission teams and guide cross-functional teams on regulatory decision-makingConduct regulatory training programs on relevant topics and review device labeling for complianceRequired QualificationsBachelor's degree in a technical or scientific field8+ years of experience in Regulatory Affairs submissions for medical devices and digital health productsExperience with FDA regulations and international standards for medical devicesTechnical proficiency in at least two relevant product categoriesAdvanced degree or regulatory certifications preferred

6 days ago
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