Regulatory Affairs Seminar Hosted By CBU

Christian Brothers University’s (CBU) Graduate Engineering Program will host a seminar on Regulatory Affairs in the Medical Device Industry Friday, October 16th, 7:30 a.m. to Noon in the Montesi Executive Center of CBU’s Buckman Hall. The seminar presenters will be Kim Armstrong, M.S.E and Christine Scifert, M.S., M.E.M.

The regulatory affairs role in the medical device industry provides a conduit to FDA oversight ensuring that product on the market is safe and effective. This seminar will cover basic concepts of regulatory affairs with a concentration towards the U.S. It is intended for persons currently in the medical device industry to learn more about the regulatory function and how regulatory interacts with other departments. It is also intended for persons desiring to become part of the medical device industry to learn the basics of regulatory affairs.

Prior to consulting, Armstrong spent three years at Medtronic Spinal and Biologics working on design control activities, annual reports, PMA supplements, change control, and labeling related to cervical and lumbar arthoplasty devices. She worked two years at Cook Med Institute developing clinical protocols and managing studies for peripheral bare metal and drug-eluting stents. Engineering principles were used to develop regulatory strategy and pre-clinical testing to obtain clearances and approvals.

Armstrong holds a Bachelor of Science in Mechanical Engineering from The University of Memphis and a Master of Science in Engineering from the Department of Aeronautics and Astronautics at Purdue University. She has completed other graduate engineering courses at The University of Memphis with an emphasis in materials.

Scifert spent nine years at Medtronic Spinal and Biologics directing the regulatory department of 22 people prior to consulting. As Senior Director of the group, she set regulatory strategy, oversaw global submissions, developed a design control process, interfaced with FDA and notified bodies, oversaw modification and implementation of procedures to maintain regulatory compliance and performed due diligence activities for potential acquisitions. Previously, she performed evaluations of injury mechanisms associated with automobile collisions, slip and falls, and sport/recreation accidents.

Scifert holds a Bachelor of Science in Physics from Hamline University, a Master of Science in Biomedical Engineering from University of Iowa and a Master of Engineering Management from Christian Brothers University.

This seminar is free and open to the public, but seating is limited. To reserve a seat, RSVP by October 12. Contact the Graduate Engineering Office at (901) 321-3282 or ###

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