Beth Stofka Ms, Rac

Beth Stofka, MS, RAC has over 20 years of work experience in various roles related to regulatory affairs.

Their most recent position is as the Director of Regulatory Affairs at GenMark Diagnostics, a role they have held since April 2022. Prior to that, they served as a Senior Manager of Regulatory Affairs at the same company starting in March 2021. Beth's tenure at GenMark Diagnostics began in April 2018 when they joined as a Manager of Regulatory Affairs.

Before joining GenMark Diagnostics, Beth worked at Thermo Fisher Scientific (Life Technologies) as a Regulatory Affairs Specialist from April 2014 to April 2018. In this role, they authored regulatory submissions and developed regulatory strategies for global submissions for IVDs.

Beth also has experience working at The EMMES Corporation as a Clinical Information Specialist from 2012 to 2013. In this role, they coordinated protocols for Phase 2 and Phase 3 trials and supported activities focused on personalized medicine and clinical trial enrollment.

Prior to their work at The EMMES Corporation, Beth was a Documentation Specialist at Leidos Health from 2009 to 2012. In this role, they provided regulatory support for clinical trials, including maintaining regulatory documents and assisting with protocol activities.

Before transitioning to the medical field, Beth served in the US Navy as a Cryptologic Technician from 1999 to 2009. In this role, they gained experience in technical operations and management, including metric analysis, training, security, and personnel management.

Overall, Beth Stofka's work experience spans both the private and government sectors, with a focus on regulatory affairs and compliance.

Beth Stofka, MS, RAC holds a Master of Science (MS) degree in Regulatory Science, which they obtained from The Johns Hopkins University in 2013. Prior to that, they completed their Bachelor of Science (BS) degree in Health Services/Allied Health/Health Sciences, General from the University of West Florida in 2009. In addition to their education, Beth Stofka has obtained certifications in Professional Networking from LinkedIn in September 2019, Regulatory Affairs from the Regulatory Affairs Professionals Society (RAPS) in December 2016, and a Certified Quality Auditor certification from ASQ - World Headquarters. The specific details regarding the obtained month and year for the Certified Quality Auditor certification are not available.