Sr Regulatory Affairs Lead: AI/ML SaMD & Fast 510k (Remote)

Innolitics LLC

Remote job

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 to completion, coordinating with engineering to ensure IEC 62304, ISO 14971, and cybersecurity deliverables stay on track. You will lead audits and client meetings, draft regulatory deliverables, perform Pre-Sub meetings, and guide junior #J-18808-Ljbffr Innolitics LLC

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Vacancy posted 2 days ago

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