Sara Gleco, PhD, Rac Devices
About Sara Gleco, PhD, Rac Devices
Sara Gleco, PhD, is a Regulatory Affairs Specialist at Teleflex in Morrisville, North Carolina, with a background in materials science and engineering and biophysics.
Title and Current Role
Sara Gleco, PhD, currently holds the position of Regulatory Affairs Specialist at Teleflex in Morrisville, North Carolina, United States. In this role, she supports product lines that include implants, reusable devices, electronic devices, sterile and non-sterile devices, and devices that incorporate software. She leads regulatory submissions for Class Is, IIa, and IIb devices and maintains regulatory data on internal systems and the FDA FURLS database.
Previous Work Experience
Before her position at Teleflex, Sara Gleco worked as a Quality Engineer at Gilero from 2020 to 2022. She also has extensive academic experience from North Carolina State University, where she served as a Graduate Teaching Assistant from 2017 to 2018 and again in 2020. Additionally, she held the position of Graduate Research Assistant at the same institution from 2017 to 2020. Earlier in her career, she worked as an Undergraduate Research Assistant at Purdue University in 2016 and as a Tutor at the University of Scranton from 2014 to 2017.
Education and Expertise
Sara Gleco received her Doctor of Philosophy (PhD) in Materials Science and Engineering from North Carolina State University, where she studied from 2017 to 2020. Prior to that, she obtained a Bachelor of Science (BS) degree in Biophysics from the University of Scranton, where she studied from 2013 to 2017. Her academic and research background has equipped her with a robust foundation in materials science and engineering.
Regulatory Affairs Responsibilities
In her current role, Sara Gleco communicates with the FDA and Notified Bodies to address submission deficiencies and collaborates with international regulatory teams for product submissions in regions outside the US, EU, and Canada. She assesses the regulatory impact of sustaining changes in the US, EU, and Canada, and provides input on regulatory strategy and DHF documentation to project teams. Additionally, she assists the MDR team with the transition from MDD to MDR and collaborates with functional SMEs in areas such as biocompatibility, sterility, and packaging.
Collaboration and Strategy
Sara Gleco works with marketing teams to develop global submission strategies for new product introductions. She reviews marketing communication materials to evaluate claims and document supporting evidence. Her efforts ensure that regulatory strategies are aligned with market needs while maintaining compliance with regional and international regulations.