Ranjana Iyer
About Ranjana Iyer
Ranjana Iyer is a Manager of Product Safety and Surveillance at AtriCure, Inc., where she has worked since 2015. With extensive experience in regulatory affairs and safety analysis, she has contributed to product improvement and compliance in the medical device industry.
Work at AtriCure
Ranjana Iyer has been with AtriCure, Inc. since 2013, serving as a Senior Safety Specialist for 11 years in Westchester, Ohio. In 2015, she was promoted to Manager of Product Safety and Surveillance, a position she has held for 9 years in the Cincinnati, Ohio area. In her role, she analyzes complaint trends and provides feedback to executive leadership, operations, and engineering personnel to facilitate product and process improvements. Additionally, she represents AtriCure's post-market complaint process during internal and external audits.
Previous Experience in Regulatory Affairs
Prior to her tenure at AtriCure, Ranjana Iyer worked at CTI Clinical Trials and Consulting from 2006 to 2010 as a Regulatory/Safety Specialist. She later served as a Clinical Safety Scientist at the same organization from 2011 to 2012. Additionally, she worked at Cincinnati Children's Hospital Medical Center as a Regulatory Affairs Specialist from 2012 to 2013. Her experience in these roles has contributed to her expertise in regulatory compliance and safety analysis.
Education and Expertise
Ranjana Iyer earned a Bachelor of Science (BS) degree from PECTS College, completing her studies from 1986 to 2001. She also studied at the University of Cincinnati, where she achieved a Clinical Research Certification from 2005 to 2006. In 2015, she attended Xavier University, where she focused on Medical Devices and completed a program in Medical Device Leadership for Patient Health and Business Success. This educational background supports her extensive knowledge in product safety and regulatory affairs.
Clinical Protocols and Risk Analysis
In her current role at AtriCure, Ranjana Iyer provides risk and safety analysis for clinical protocols. She reviews clinical trial adverse events and is responsible for reporting these events to the FDA. Her expertise in this area ensures compliance with regulatory requirements and enhances the safety of clinical practices.
Audit Representation and Compliance
Ranjana Iyer plays a key role in representing AtriCure's post-market complaint process during internal and external audits. Her involvement in these audits demonstrates her commitment to maintaining high standards of compliance and safety within the organization.