Jonathan K.
About Jonathan K.
Jonathan K. is a Regulatory Product Specialist at Teleflex with extensive experience in post-market surveillance and quality assurance.
Title
Jonathan K. holds the position of Regulatory Product Specialist, MDR at Teleflex. His role includes preparing regulatory submissions, participating in product development, and ensuring regulatory compliance of various documents and procedures.
Current Role at Teleflex
In his current role at Teleflex, Jonathan K. prepares regulatory submissions, including pre-submission requests and post-approval submissions. He is also responsible for involvement in project team meetings for product development, including risk assessments. He reviews and approves test protocols and documents to ensure they meet regulatory requirements, and additionally trains other departments on market authorization, promotional, and advertising topics.
Previous Positions
Jonathan K. has held multiple positions at Teleflex, showcasing a diverse range of responsibilities. He worked as a Sr. Post Market Surveillance Specialist from 2020 to 2021, and as a Post Market Surveillance Specialist from 2019 to 2020. Before that, he was a Post Market Surveillance Coordinator in 2018, a Shipper from 2017 to 2018, a Receiver in 2017, and a Packaging Operator from 2013 to 2017. He also worked briefly at Quanterix as a Quality Assurance Complaints specialist in 2021.
Educational Background
Jonathan K. has an extensive educational background. He earned a Master's degree in Regulatory Affairs - Medical Device from Northeastern University (2021-2023). He also holds a Bachelor's degree in Business Administration and Management from Manning School of Business, UMass Lowell (2018-2020) and an Associate's degree in Business Administration from Middlesex Community College (2012-2017).
Regulatory and Compliance Expertise
Jonathan has a proven track record in regulatory and compliance activities. His responsibilities include reviewing and approving product labels, instructions for use, and promotional materials. He analyzes changes for regulatory impact and communicates these impacts effectively to teams. Additionally, he is skilled in identifying regulatory compliance problems and recommending appropriate solutions, as well as researching and presenting training on market authorization, promotion, and advertising trends.