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Regulatory Affairs Specialist II

Cook Group • Vandergrift, PA, US • published 2026-11-03 03:17:06.349168

Description

The Regulatory Affairs Specialist II is responsible for the planning and preparation of submissions to obtain regulatory approvals for new and modified medical devices in specific markets. The Regulatory Affairs Specialist II develops regulatory strategies, obtains and maintains approvals, and serves as a communication liaison between the Cook manufacturer and the Cook International Local Office / Cook Distributor.* Maintain an excellent understanding of global medical device regulations regarding the following: ISO 13485, MDR 2017/745, FDA 21 CFR Part 820 and others as required. * Serve as a liaison on regulatory issues between the Cook manufacturer and Cook Local Office and/or Cook Distributor and Notified Body. * Prepare regulatory submissions for new products, product changes, and re\-registrations as required for the specific regions. * Create, organize, and maintain technical documentation. * 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. * Provide support to currently marketed products as necessary including input on/ creation ...

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