Clinical Regulatory Specialist
Actalent · Eagleville, PA · 2 wk ago
On-siteLegal$80k–$85k/yrFull-time
About the role
The Clinical Regulatory Specialist supports the development, preparation, and submission of U.S. regulatory filings for Class II and Class III medical devices. This role partners closely with Product Development, Clinical Affairs, and other internal teams to prepare and review 510(k) submissions, coordinate supporting documentation, obtain final approvals, and respond to FDA requests. The Specialist assists with IDE and PMA submissions, contributes to nonclinical, manufacturing, and clinical sections of PMA packages, reviews clinical study data for regulatory reporting, and supports the ongoing maintenance of approved PMAs.
This is a permanent, full-time