Hyman, Phelps & McNamara, P.C. (HPM) pleased to announce Allyson B. Mullen has become its newest Director. Allyson joined HPM in June 2013. Since that time, her years of service have made significant contributions to the firm and its clients.
Prior to joining HPM, Allyson served as in-house counsel at Waters Corporation. Earlier in her career, Allyson also worked in regulatory affairs for medical device companies including Boston Scientific and Johnson & Johnson. In these roles Allyson gained a deep understanding of both the regulatory and business considerations of medical device clients.
As a Director, Allyson will continue to provide counsel to medical device and in vitro diagnostic (IVD) manufacturers. Allyson assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters.
In the premarket area, Allyson prepares IDEs, 510(k)s, de novos, and PMAs. She also prepares pre-submissions, and assists clients in preparing for and represents clients at pre-submission meetings with FDA. In the postmarket area, she advises clients on complaint handling, MDRs, field actions, and QSR compliance. Ms. Mullen also helps clients with contract matters and regulatory due diligence. Allyson’s full bio can be found here.