- Globus Medical, Inc. (Audubon, PA)
- …preparing, filing and gaining approval of 510(k), IDE, and PMA submissions to the US Food and Drug Administration (FDA) for class II and class III products. This ... and line extensions. + Assists in review of product labeling and marketing materials. + Provides regulatory ...product labeling and marketing materials. + Provides regulatory oversight of changes in manufacturing facilities, processes, and… more
- Globus Medical, Inc. (Audubon, PA)
- …and gaining clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. ... needed for IDE and PMA reporting + Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performing routine… more
- Teleflex (Wyomissing, PA)
- …Support regulatory compliance activities, including Health Canada license renewals, Food and Drug Administration (FDA) product device listings, establishment ... Sr. Regulatory Affairs Associate **Date:** Nov 24, 2025 **Location:**...* Knowledge and experience with design control, change assessments, labeling requirements, etc. * Experience and knowledge of Quality… more