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Rhythmlink

Senior Medical Device Regulatory Lead

columbia, SC

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Job description

Rhythmlink in Columbia, SC is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for new product development and lifecycle management, including cross-functional collaboration with engineering, quality, and clinical teams.

You will develop EU MDR technical documentation, manage 510(k) submissions, and monitor global regulatory requirements to maintain market authorizations and ensure audit-ready records.

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Worksite address

columbia, SC, 29228, US

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