Angela has worked within the medical device industry for over 30 years for companies such as Zimmer, Ev3 and St. Jude Medical before she turned to consultancy. At NAMSA, Angela works with innovative medical device companies to assist them in the development and implementation of regional and global regulatory strategies. This experience encompasses writing and implementing successful Breakthrough and Safer Technologies Program (STeP) submissions, a passion for pre-submissions and an interactive approach to working with FDA. She has a depth of experience with 510(k)s, Investigational Device Exemption (IDE), Premarket (PMA), De Novo and Humanitarian Device Exemption (HDE) submissions.

CORE COMPETENCIES

• Develops regulatory strategies for novel and next generation medical devices to address regulatory requirements and best practices, while appreciating the nuances of business needs
• Assists in developing regulatory strategies for small companies to make them attractive for acquisitions or allowing them to change the world
• Acts as Program Director for complex regulatory projects to ensure timelines are met effectively and efficiently
• Develops regulatory strategies that include pre-sub strategies with the U.S. Food and Drug Administration (FDA); helps companies through the pre-sub process
• Serves as a stand in for Sponsor’s Regulatory VP role, including interviewing staff, assisting in recall strategies/FDA warning letters and 483 issues
• Reviews device/design changes and serves as an independent reviewer for product development
• Has received Breakthrough and/or Safer Technologies Program (STeP) designation on 12+ devices

• Serves and presents on industry panels and workshops with the FDA to discuss regulatory and clinical strategies, and Breakthrough, EFS and IDE programs
• Mentors and serves as a sounding board for small companies to develop and implement the best regulatory strategy for a given situation

RECENT PROJECTS

• Recent projects include work on BCI Systems, tendon and nerve protectors to prevent tissue attachment; drug delivery systems for gene therapy, combination products, and thrombectomy and distal protection devices