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Innolitics LLC is a remote-first medical device consultancy hiring a Principal Regulatory Affairs Specialist to guide AI/ML-enabled SaMD through the FDA lifecycle. You will craft regulatory strategies, oversee clinical validation planning, and lead Pre-Submissions for strategic
Innolitics LLC is a remote-first medical device consultancy hiring a Senior Regulatory Affairs Specialist to lead regulatory engagements for AI/ML-enabled SaMD. You will shape regulatory strategy, advise on FDA AI/ML framework, and drive Fast 510(k) sprints
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