Regulatory Affairs Specialist II

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, prepare moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), CE-Mark Technical Dossier, UKCA Mark, other regional Regulatory submissions, non-US Clinical Trial Submission, Shonin, and Certificates to Foreign Government • Track multiple projects concurrently • Ensure that existing approvals and documentation are maintained • Communicate with in-country RA personnel to facilitate global clearance/approvals • Monitor, research, and obtain information on FDA clearances/approvals of competitors, and proactively share this information with interested parties • Communicate with regulatory agencies under direct supervision • Perform reviews with some oversight of design control documents (e.g., engineering protocols, reports, product drawings, etc.), quality system procedures relating to commercialization, labeling (e.g., Instructions for Use, product labels, promotional materials), and risk management to ensure regulatory compliance.  • Assist in performing moderately complex research to support strategic planning • Analyz