All jobs → Partner boards

Regulatory Affairs Specialist I

Cook Group • Bloomington, IN, US • published 2026-11-05 06:59:20.726712

Description

The Regulatory Affairs Specialist 1 is responsible for the planning and preparation of submissions to obtain regulatory approvals for new and modified Class I, II, III and IV medical devices in specific markets. In addition to submissions, the Regulatory Affairs Specialist I will serve as a communication liaison between the Cook manufacturer and the Cook Local Office / Cook Distributor.* Serve as a liaison on regulatory issues between the Cook manufacturer and Cook Local Office and/or Cook Distributor. * Communicate region\-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assists with the regulatory strategies. * Prepare regulatory submissions for new products, product changes, and re\-registrations as required for the specific regions. * Maintain registration information (license numbers, expiration dates, etc.) and obtain re\-registration approvals in advance of license expirations to ensure no disruption in product availability. * Collaborate with Regulatory Scientific Affairs on all high risk devices and new technologies. * Collaborate with the Clinical Functional Unit on projects requiring the collection of clinical data. * Prov...

Get jobs like this daily in Telegram: @careeri_bot