Evan L. Rosenfeld

About Evan L. Rosenfeld

With over 30 years of combined experience as an in-house corporate executive, consultant, and outside counsel, I am both a licensed physician (TX/CA) and a practiced regulatory attorney who provides strategic insight and direction in the areas of medical affairs, regulation, and clinical activity/research for healthcare products. Over the years, I have worked at all stages of medical, clinical, regulatory, and compliance activities for healthcare technologies spanning the broad range of medical specialties and indications for use. My past employers and clients include manufacturers of healthcare products (including medical device, pharmaceutical, biotechnology, in vitro diagnostic, and combination products), contract research organizations (CROs), venture capital and financial investment concerns, global medical device consulting groups, and law firms.I perform all of my medical/clinical/regulatory strategic activities with the ultimate goals of maximizing medical and scientific validity and impact for both marketing and clinical activities, minimizing product-related significant and other types of adverse events (SAEs/AEs), guiding submissions for both investigational activities and market approvals, negotiating in these areas with the relevant authorizing agencies and boards, ensuring conformity with post-market requirements, maximizing the potential for ultimate insurance coverage and reimbursement, ensuring compliance with Good Clinical Practices (GCPs), and streamlining potential regulatory pathway(s) to market.My medical specialty is Physical Medicine and Rehabilitation (PM & R), with a focus on treating pain, central/peripheral neurological system (CNS/PNS) diseases and injuries, orthopaedic, musculoskeletal, and rheumatological conditions, and having broad clinical experience in general internal medicine, as well.

Experience

1. Medical Affairs Director (Global)

   Philips

   Sep 2018 — Present · US

   Global Medical Affairs Director for worldwide Precision Diagnosis business cluster, which includes Diagnostic Imaging (MR, CT, SPECT, PET, DXR, etc.), Ultrasound, and Healthcare Informatics (Oncology Solutions, Oncology Informatics, Radiation Oncology, Emerging Businesses (such as Pathology and Neurology Solutions), Radiology Solutions, and Intellispace Discovery). Key areas of responsibility include:• Input into unmet medical/clinical needs for business strategies to optimize both current portfolios and New Product Development• Risk management and safety oversight across relevant end-to-end processes, including medical input into product development and clinical study, submissions for regulatory approval to market, adverse event reporting, complaint handling, Health Hazard Evaluations, CAPA\'s, risk management matrices, risk-benefit analyses, Field Action Committees, Risk Management Review Boards, and Complaint Review Boards• Medical input into Clinical Evaluation Plans and Reports, and accountable for medical risk/benefit assessments• Medical input into Marketing Communications and Review, promotional issues, and other corporate activities relating to dissemination of scientific information• Medical/Legal input regarding products liability issues• Medical Science Liaison direction and oversight• Support Medical Information Requests from external customers• Primary medical and clinical Subject Matter Expert for addressing relevant business matters• Develop pre- and post-market clinical/medical documentation

Education

• University of Pennsylvania Carey Law School

  J.D., Law

  1988 — 1991

• Virginia Commonwealth University School of Medicine

  M.D., Medicine

  1996 — 2000

• Harvard University

  A.B., Neurobiology

  1984 — 1988