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Senior Medical Device Regulatory Strategist

columbia, SC

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Job description

Rhythmlink seeks a Senior Regulatory Affairs Specialist to independently support regulatory activities for domestic and international medical devices. You will lead regulatory strategy, develop technical documentation, and ensure lifecycle compliance across design changes and product updates.

The role emphasizes cross-functional leadership, audit readiness, and maintaining market authorizations, including biocompatibility, sterilization, labeling, and software validation where applicable.

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Worksite address

columbia, SC, 29228, US

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