Regulatory Affairs Specialist I

Penumbra, Inc. • Alameda, CA, US • published 2026-09-19 05:37:23.288359

Description

In this role, you will work with the team that ensures that Penumbra products are approved for use in countries around the world, thereby helping to bring our life\-saving technologies to patients worldwide. You will be responsible for the coordination, preparation, and maintenance of document packages for worldwide regulatory submissions. **What You’ll Work On** * Under direct supervision, assist in preparing various submissions to gain approvals, such as 510(k), CE Mark Technical Documentation, UKCA Mark, other regional Regulatory submissions, IDE, non\-US Clinical Trial Submission, Shonin, and Certificates to Foreign Government * Assist in the tracking of multiple projects concurrently * Ensure that submission/approval documentation is maintained per internal procedures * Support in\-country RA personnel to facilitate global clearance/approvals. * Research and obtain information on Regulatory Intelligence such as competitor product information and approvals, new or updated regulations/guidance, as directed. * Support labeling reviews (e.g., Instructions for Use and product labels). * Train in existing systems, Work Instructions, and SOPs as needed to support departmental functio...

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