Jackie Rae Elkin

Medtronic, Global Process Owner - Standard Product Identification, Global Regulatory Affairs
Plenary: 
Panel – Public policy: Medical Devices
Topic: 
Wednesday, 31 Oct | 16:00 – 17:15

Jackie has been working in the medical device sector for more than 30 years and currently holds the position of Global Process Owner of Standard Product Identification for Medtronic Global Regulatory Affairs.  

Jackie has been recognized in the healthcare sector as a leader and SME in global product identification standards development and implementation, both internally to Medtronic, and to the global healthcare industry.  She has co-chaired the AdvaMed Auto-Identification Committee since 2006, providing guidance on product identification standards related to the FDA’s Unique Device Identification (UDI) legislation.  She has also provided advisory role in many other initiatives involving UDI legislation in both the United States and around the world. Jackie has represented the medical device industry in the International Medical Device Regulators Forum (IMDRF) UDI Work Group, the Global Medical Device Nomenclature (GMDN) Policy Advisory Group, the China International Medical Device Regulatory Forum (CIMDR) and has also been appointed to the EU Commission EUDAMED UDI Work Group.   

Jackie is one of the founding members of GS1 Global Healthcare and has maintained a leadership role in the organization since its inception in 2005.  She has also been involved in many of the GS1 Global Healthcare work teams, developing global standards for product identification and Auto-Identification Data Capture (AIDC) in healthcare. Jackie also co-chairs the GS1 Global Healthcare Public Policy work group. In this role, she has engaged with medical device regulators around the world to provide guidance on implementation of global healthcare standards. Jackie is very active in advocating for implementation of globally harmonized standards for regulatory submissions of device identification information at different points in the medical device regulatory life cycle.