Program Manager, Regulatory Affairs

In this role, you will be primarily responsible for handling regulatory affairs requirements for medical devices and biologic products, including Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). You will develop regulatory strategies and regulatory submissions for new and modified products to the FDA and International regulatory bodies. This individual will also provide regulatory support and guidance for product changes to US marketed products. Responsibilities include working closely with process development, manufacturing, and quality departments to support the preparation of domestic and international regulatory submissions. This includes writing, reviewing, and editing technical reports and regulatory documentation, providing input on and reviewing protocols and reports including but not limited to process validation, equipment qualification, and shelf-life studies, ensuring regulatory compliance with QSR and cGMP requirements, and reviewing labeling changes and advertising materials.