The University of St. Thomas

School of Engineering

Kristina Simmons

Kristina Simmons

Kristina K. Simmons

Adjunct Faculty

kksimmons@stthomas.edu
Phone: 651-962-5750

Mail  OSS100
2115 Summit Ave.
St. Paul, MN 55105

Office Location:

Interests and Expertise

Leadership, Regulatory Affairs, Clinical Research, Medical Device Product Development

 

Career

Kristy Simmons is an Engineering Program Director in the Cardiac Rhythm Disease Management Group at Medtronic.  She leads a cross functional team in the product development activities for life saving medical technology.

 

Ms. Simmons spent 12 years in the Clinical Research and Regulatory Affairs Organizations at Medtronic where she was responsible for the leadership of multiple clinical programs and the strategic implementation of regulatory activities to ensure compliance and timely global commercialization of products. 

 

Ms. Simmons is proficient in all U.S. submission types; including Original PMA, PMA-S, 510(k), IDE, Advisory Panels, post market surveillance, and post-approval submissions.  Ms. Simmons has experience with combination products and pharma GMPs.  She has international regulatory expertise in the European Union, Japan, Canada, and Australia.  

 

Before joining Medtronic, Ms. Simmons held positions in the areas of Sales, Quality Systems, and Regulatory Affairs at Empi Medical and MinRad / BioVector.

 

Education and Professional Affiliations

B.S., Biology  - Saint Norbert College

M.S., Manufacturing Systems - University of Saint Thomas 

Regulatory Affairs Certification (RAC).