Jennifer Newberger Returns to HPM as a Director After Stints with Apple, Abbott Laboratories, and Cognito Therapeutics

Hyman, Phelps & McNamara, P.C. (HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice. Jennifer’s combination of experiences as in-house counsel for both large and start-up companies as well as outside counsel provides clients invaluable expertise and problem-solving skills.

Jennifer has deep experience helping clients in matters including development of regulatory strategy, preparation of regulatory submissions, development and implementation of policies and procedures, review of advertising and promotional materials, regulatory aspects of commercial transactions, and responding to enforcement matters from FDA or other agencies.

On the premarket side, in addition to the preparation of pre-submission and submission materials for FDA, Jennifer assists clients in responding to inquiries from FDA during the review process and participating in meetings with clients to address FDA concerns. On the postmarket side, she advises clients on regulatory compliance matters, including complaint handling, MDRs, field actions, promotional review, and QSR compliance. Jennifer also helps clients with contract matters, regulatory due diligence, and public filings. She also specializes in medical device software and digital health.

“Jennifer’s return adds depth and breadth to our device practice and her strong relationships from her earlier time at the firm has made for a seamless reentry,” said J.P. Ellison, Managing Director at HPM.

Jennifer was with the firm from 2011-2017, before leaving for in-house roles at Apple, Abbott Laboratories, and Cognito Therapeutics. At Apple, she led executive-level meetings, including with the Chief Operating Officer, regarding regulatory and legal challenges associated with shipping regulated health features. She also managed the cross-functional team responsible for obtaining Apple’s first de novo authorizations for the ECG app and irregular rhythm notification.

With her return to the firm, she can now utilize her recent in-house experience to help HPM’s diverse client base solve complex problems.

“Having worked with Jennifer for six years previously, I am truly excited to have her return.  She was an outstanding lawyer before, and her in-house experience will provide even greater breadth and depth of expertise to medical device manufacturers,” notes Jeffrey Gibbs, HPM Director.