Senior Regulatory Affairs Manager- REMOTE - Tallahassee
1 month ago

Job summary
This is a customer-funded position. Supports North America Regulatory activities Ensure timely preparation and completion of technical file submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs Ensure participation on cross functional project teams to provide strategic and tactical guidance to meet regulatory requirements Develop North America regulatory strategies plan for submission for IVD products Assess changes to product manufacturing processes labeling affecting IVD products communicate to global Regulatory and project teams for impact assessment Support global Regulatory teams in-country dealers representatives with regulatory registrations of IVD products Maintain up-to-date knowledge ofIVD regulations applicable guidance monitor development communicate impact to the business Provide input feedback on clinical study protocols ensure regulatory requirements are incorporated Support CE marking activities importation exportation permitting activities Review approve promotional materials product labeling
Job description
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