Danielle Mc Donnell Boyd
About Danielle Mc Donnell Boyd
Danielle Mc Donnell Boyd serves as the Senior Director of Regulatory Affairs and Quality Assurance at Cala Health, where she has worked since 2022. She has extensive experience in regulatory submissions and approvals, with a background that includes roles at AEGEA Medical, Invicta Medical, and Broncus Technologies.
Work at Cala Health
Danielle Mc Donnell Boyd currently serves as the Senior Director of Regulatory Affairs and Quality Assurance at Cala Health. She has held this position since 2022. In her role, she is responsible for overseeing regulatory strategies and ensuring compliance with quality assurance standards. Prior to this position, she worked as the Director of Regulatory Affairs at Cala Health from 2021 to 2022.
Previous Experience in Regulatory Affairs
Before joining Cala Health, Danielle Mc Donnell Boyd held several positions in regulatory affairs. She worked at AEGEA Medical, Inc. as a Regulatory Affairs Manager from 2017 to 2018 and previously served as a Senior Regulatory Specialist and Clinical Regulatory Specialist at the same company from 2011 to 2017. Additionally, she was the Associate Director of Regulatory and Clinical Affairs at Invicta Medical from 2018 to 2020.
Clinical Research Background
Danielle Mc Donnell Boyd began her career in clinical research, working as a Clinical Research Assistant at Broncus Technologies from 2007 to 2009. She then transitioned to PulmonX, where she served as a Clinical Regulatory Associate from 2009 to 2011. These roles provided her with foundational experience in clinical and regulatory processes.
Education and Expertise
Danielle Mc Donnell Boyd earned her degree from the University of California, Santa Barbara, where she studied from 1998 to 2002. She possesses expertise in obtaining regulatory approvals for medical devices, including CE-mark, 510(k), IDE, and PMA for Class II and III devices. Her skills also include strategic negotiations and cross-functional collaboration.
Achievements in Regulatory Submissions
Danielle Mc Donnell Boyd has a successful track record in writing and driving complex regulatory submissions on time. She is recognized for her creative problem-solving abilities within the regulatory affairs domain, contributing to her effectiveness in navigating the regulatory landscape for medical devices.