Andrea L. Ruth, M.S,

Andrea L. Ruth, M.S has a diverse work history in the field of regulatory affairs and quality assurance within the medical device and combination product industry. Andrea L. is the Principal Consultant at ALR Consulting, LLC, a consulting firm specializing in medical device regulatory affairs, clinical affairs, and quality assurance. Andrea has been with ALR Consulting since 2006 and continues to lead the expansion of the company.

In addition to their role at ALR Consulting, Andrea has held various positions in other organizations. From 2021 to the present, they served as the SVP of Regulatory Affairs at NeVap. From 2012 to 2013, they were the Senior Director of Regulatory Affairs and Quality Assurance at PhotoThera. Prior to that, from 2010 to 2012, they served as the Senior Director of Regulatory Affairs and Quality Assurance at a stealth mode start-up company.

Andrea's previous experience includes working as an RA/QA Consultant at Volcano Corporation from 2008 to 2009, where they successfully addressed a significant backlog of complaints. Andrea L. also worked as an Associate Consultant at Marion Weinreb and Associates from 2008 to 2009, specializing in regulatory consulting, submissions, and technical writing. In 2008, they served as a Consultant in Regulatory Affairs at Oraya Therapeutics and as the Director of Quality Assurance and Regulatory Affairs at Diamics, Inc. on a consulting basis from 2007 to 2008.

Andrea began their career in regulatory affairs at Hansen Medical in 2006 as a Manager of Regulatory Affairs on a consulting basis. Prior to this, they worked in regulatory affairs at Guidant Cardiac Surgery from 2005 to 2006.

Throughout their career, Andrea has demonstrated expertise in medical device regulatory affairs, clinical affairs, quality assurance, and submissions.

Andrea L. Ruth, M.S., is currently pursuing a Ph.D. in Clinical Psychology from Walden University, with an expected completion date in 2025. Andrea L. attained a Master of Science (M.S.) degree in Organizational Leadership from Colorado Technical University, which they completed between 2015 and 2016. Prior to that, they pursued studies in Law/Business at Santa Clara University from 2000 to 2002. Andrea L.'sundergraduate studies were in Biology and Psychology at the University of California, Davis, where they obtained a Bachelor of Science (BSc) degree from 1993 to 1997.

Furthermore, Andrea L. Ruth has additional certifications to complement their academic qualifications. In December 2012, they obtained the Regulatory Affairs Certification (RAC) from RAPS. Additionally, in June 2012, they acquired the Certified Quality Auditor (CQA) certification from ASQ.