Rosa Hernández Phillips, Rac
About Rosa Hernández Phillips, Rac
Rosa Hernández Phillips is the Manager of Regulatory Affairs (Neuromodulation) at Boston Scientific, with extensive experience in managing regulatory submissions for active implantable and Class III medical devices.
Title
Rosa Hernández Phillips currently holds the position of Manager, Regulatory Affairs (Neuromodulation) at Boston Scientific. She has been in this role since 2018, based in Valencia, CA.
Work Experience at Boston Scientific
Rosa Hernández Phillips has an extensive history at Boston Scientific, working in various capacities within the regulatory affairs department. Before her current managerial role, she was the Principal Specialist in Regulatory Affairs (Neuromodulation) from 2015 to 2018. Prior to that, she served as a Senior Regulatory Affairs Specialist (Neuromodulation) from 2010 to 2015.
Previous Positions in Regulatory Affairs
Rosa's regulatory affairs career includes significant roles at several other organizations. She was a Regulatory Affairs Consultant at Alfred Mann Foundation for three months in 2010 and worked as an Independent Contractor in Regulatory Affairs at MannKind Corporation from 2009 to 2010. She also held the position of Manager, Regulatory Affairs at NeuroSystec Corp. from 2008 to 2009. Rosa has accumulated extensive experience over the years by holding various regulatory affairs positions at other companies, including MannKind Corporation, Allecure, and Medicis.
Expertise in Regulatory Submissions
Rosa Hernández Phillips specializes in managing regulatory submissions for active implantable devices and Class III medical devices. She has extensive experience providing regulatory support throughout the entire product lifecycle, from proof of concept to post-market compliance. Her expertise includes handling submissions to international regulatory agencies like the US FDA, European Notified Body, and Health Canada.
Experience in Clinical Trials and Compliance
Rosa is well-versed in regulatory aspects of Phase I to III clinical trials and electronic submissions. Her experience includes promotional review and ensuring compliance within the regulatory affairs domain. Her specialization in various therapeutic areas such as Neuromodulation, Allergenic Vaccines, Immunotherapy, Oncology, and Dermatology underscores her versatile background in medical regulation.