Amy O'Donnell

Amy O'Donnell has a strong background in regulatory affairs and quality assurance. Amy is currently working as the Senior Director of Regulatory and Quality Affairs at OnPoint Surgical, Inc. Prior to that, they were the Regulatory Affairs Lead at LifeScan from June 2018 to April 2019. Amy also worked as a Postmarket Surveillance Specialist at The Janssen Pharmaceutical Companies of Johnson & Johnson from October 2016 to June 2018. Amy's earlier experience includes roles as a Senior Regulatory Affairs Specialist at ConforMIS, Inc. from October 2011 to October 2016, and as a Complaint Specialist, Recall Specialist, and Document Controller at Synthes from March 2007 to September 2011. In these positions, they were responsible for various regulatory and compliance activities, including 510(k) submissions, complaint handling, MDR submissions, recall coordination, and documentation management. Amy has a proven track record of ensuring regulatory compliance and maintaining high quality standards in the medical device industry.

Amy O'Donnell earned a Certificate in Biopharmaceutical Domestic Regulatory Affairs from Northeastern University in 2009-2010. Prior to that, they obtained an MBA degree in Accounting and Finance from Rochester Institute of Technology in 2005-2006. Amy'sundergraduate education was also completed at Rochester Institute of Technology, where they received a Bachelor of Science degree in Bioinformatics from 2001-2005. Amy O'Donnell has additional certifications such as RAPS Member from the Regulatory Affairs Certification Program in January 2010, RAC-EU from the Regulatory Affairs Certification Program in June 2013, and RAC-US from the Regulatory Affairs Certification Program in June 2010. Amy also holds a Six Sigma Green Belt certification, although the specific month and year of its acquisition are not provided.