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About Us

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René Hardee

Director

Regulatory Affairs & Program Management

  • LinkedIn

Rene’ is the Director of Regulatory Affairs and Program Management for MedSec. She manages the compliance team and partners with clients to help meet their cybersecurity needs, whether that be though regulatory submission preparation, submission defense, or program maturation.

 

With over 15 years of experience in the Medical Device industry, Rene's roles have ranged from R&D, Quality, Regulatory Intelligence, and Regulatory Affairs. Early in her career, you could find her launching rockets and calculating trajectories of solid rocket boosters at Kennedy Space Center in Florida. Since then, Rene' had transitioned into the Medical Devices industry to help establish devices for radiation oncology and women's healthcare. Nowadays, Rene' has honed her years of Regulatory expertise to focus on helping medical device manufacturers elevate their cybersecurity programs with MedSec.

Rene’ holds both a Bachelor of Science degree and a Master’s degree in Astrophysics from Florida Institute of Technology and Vanderbilt University respectively.

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