Amy O'donnell
About Amy O'donnell
Amy O'Donnell is a Senior Regulatory Affairs Specialist at ConforMIS, Inc., where she has worked since 2011. With a strong background in regulatory compliance and quality management, she has facilitated successful 510(k) notifications and developed regulatory strategies for medical devices.
Work at ConforMIS
Amy O'Donnell has been employed at ConforMIS, Inc. as a Senior Regulatory Affairs Specialist since 2011. In this role, she has developed regulatory strategies for multiple medical devices across various geographies, ensuring compliance with international standards. Her responsibilities include facilitating 510(k) premarket notifications for new and modified proprietary software modules, achieving a 100% success rate in obtaining substantially equivalent decisions. Additionally, she has conducted quarterly internal audits on the Quality Management System, contributing to continuous improvement and compliance.
Previous Experience at Synthes
Prior to her current role, Amy O'Donnell worked at Synthes in various capacities. She served as a Recall Specialist from 2009 to 2010, where she focused on managing product recalls. Following this, she worked as a Complaint Specialist from 2010 to 2011, handling customer complaints and ensuring regulatory compliance. Additionally, she held the position of Document Controller from 2007 to 2009, managing documentation processes and ensuring adherence to regulatory requirements.
Education and Expertise
Amy O'Donnell holds a Certificate in Biopharmaceutical Domestic Regulatory Affairs from Northeastern University, which she completed from 2009 to 2010. She also earned an MBA in Accounting and Finance from the Rochester Institute of Technology in 2006. Furthermore, she obtained a Bachelor of Science in Bioinformatics from the same institution, graduating in 2005. Her educational background supports her expertise in regulatory affairs and compliance within the medical device industry.
Regulatory Compliance Initiatives
Throughout her career, Amy O'Donnell has initiated several key compliance initiatives. She has conducted internal training sessions focused on quality management systems, advertising and promotion for medical devices, and software validations. These sessions have enhanced team knowledge and compliance with regulatory standards. Additionally, she has participated in third-party audits, including those conducted by Notified Bodies and the FDA, showcasing her expertise in regulatory compliance.