- Cardinal Health (Harrisburg, PA)
- **What Regulatory Submissions Operations contributes to Cardinal Health** Regulatory provides regulatory affairs and product development consulting ... subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting. … more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance ... for 510(k) submissions , and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist , Regulatory Affairs...of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, ... including Premarket Notifications and Technical Documentation for CE Marking. The Senior Specialist ensures timely and high-quality execution of all… more