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Duke University Health System
Durham, North Carolina
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Mid-level Medical Device Associate
Hyman, Phelps & McNamara, P.C. (HP&M) seeks to add a 4th to 6th year associate to its medical device team. Our team assists clients with a wide variety of pre- and post-marketing regulatory topics. Types of matters include: Developing regulatory strategy for obtaining marketing authorization Preparing regulatory submissions, including IDEs, 510(k)s, de novos, and PMAs Meeting with FDA on behalf of clients seeking marketing authorization and in other interactions with the Agency Advising on and developing policies for regulatory compliance matters including complaint handling, field actions, recalls, and promotional review Conducting due diligence of medical device manufacturers Strong verbal and writi
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