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Medline

Remote Senior Regulatory Affairs Lead (Medical Devices)

northfield township, IL

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Job description

Medline Industries in Illinois seeks a Senior Regulatory Affairs Specialist for our Quality division. This remote role oversees global regulatory projects to obtain and maintain approvals, guiding complex strategies for devices across markets.

You will lead submissions (510(k)s, CE Technical Files), coordinate with internal teams and regulators, and mentor cross-functional groups on regulatory requirements while ensuring compliance and audit readiness. Travel up to 10% may be required.

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