Regulatory Affairs Specialist I

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 functions and the Quality System. • Understand Quality System regulations (ISO 13485), Design Control, and regional Regulatory requirements • Support Regulatory change assessment for product changes.   What You Contribute • A Bachelor’s degree in a relevant discipline or an equivalent combination of education