Stephanie Seidel

Senior Principal Regulatory Affairs Specialist, Robotic Surgical Technologies (RST) at Medtronic

Speaker

Stephanie Seidel has over 20 years of medical device experience. She has over 16 years in regulatory affairs, including over 8 years in regulatory leadership roles, and 3 in clinical research working on hybrid regulatory/clinical projects with global reach.

As a senior regulatory leader, she and her teams strategized and implemented successful regulatory strategies in over 90 global markets. Stephanie has authored or collaborated on 150+ approved US and international regulatory submissions for devices in Classes I through III, including implantables and novel devices. Stephanie has broad technical expertise, with multi-product active and passive implantable systems, software, wireless devices, surgical tools, electromechanical hardware, and combination drug/device and device/biologic products. Device expertise includes cochlear implant systems, endovascular intervention devices, neuromodulation systems and blood processing devices.

Stephanie has been developing and collaborating on global clinical evidence strategies for over 10 years. Recently, she has distinguished herself as a senior clinical evaluation strategist and author for the EU MDR, China and other global markets. She volunteers on many community-building projects within Medtronic and for RAPS to serve the regulatory affairs community. Currently, Stephanie is a Sr Principal Clinical Evaluation Specialist with Medtronic Peripheral Vascular Health.