Angela Drysdale

About Angela Drysdale

At the core of my professional journey is a steadfast commitment to bridging the gap between innovation and compliance in the medical device and diagnostics sector. I am deeply passionate about streamlining regulatory processes to bring life-changing products to the market while ensuring the highest standards of safety and efficacy. My guiding philosophy is centered on proactive collaboration and strategic foresight, paving the way for breakthroughs that enhance patient care and drive industry advancements. With extensive experience as a regulatory affairs executive, I possess a comprehensive understanding of global regulatory landscapes, quality system regulations, and clinical study design. My expertise lies in navigating complex regulatory environments, orchestrating strategic planning, and leading cross-functional teams to achieve timely product approvals. I specialize in regulatory strategy development, submission management, and maintaining compliance with FDA, Health Canada, CE Mark, and other international regulatory bodies. Throughout my career, I\'ve had the privilege of making significant contributions to the industry, including playing a pivotal role in obtaining FDA EUA approval for the first COVID-19 test for home use. My tenure at Abbott Rapid Diagnostics was marked by the successful development and implementation of regulatory strategies that facilitated the global distribution of innovative medical devices. Additionally, being honored with Abbott\'s Chairman’s Award and the Regulatory Affairs Leadership Award underscores my dedication to excellence and leadership in the field. I am eager to leverage my extensive regulatory expertise to collaborate with forward-thinking organizations aiming to innovate and expand in the healthcare sector. By providing strategic guidance and fostering environments of regulatory excellence, I aim to create pathways for cutting-edge products that improve lives globally. Let\'s connect to explore how I can help your organization navigate the ever-evolving regulatory landscape and achieve remarkable outcomes.

Experience

1. Divisional Vice President, Regulatory Affairs - Infectious Disease

   Abbott

   Oct 2017 — Present

   Enabled development, manufacturing, and distribution of products to meet required legislation, ensuring global registration. Established organizational structure, regulatory strategy, and expedient pathway to market for new product development. Performed strategic planning, design, implementation, and execution of programs in alignment with corporate goals. Analyzed and compared regulatory outcomes with initial product concepts and recommended future strategies and actions. Maintained annual licenses, registrations, and listings.• Developed global regulatory strategies, anticipating emerging issues and updating based upon regulatory changes.• Directed regulatory strategy and regulatory submissions, including FDA (510(k), CLIA waiver, PMA, pre-submission), Health Canada, CE mark (technical files), Japan, and other OUS registrations. Ensured import/export of products complied with applicable regulations.• Played a pivotal role in the timely attainment of FDA EUA approval of the first visually read COVID-19 test for home use.• Recruited, developed, managed, and mentored regulatory professionals to contribute to organizational / human capital planning. Provided strategic guidance for resource and development planning.• Communicated goals, activities, and outcomes to senior management, identifying gaps and resolutions to business strategies.• Negotiated with regulatory authorities during development and review process to ensure submission approval. Provided strategic input and technical guidance on regulatory requirements to corporate and management stakeholders. Ensured preapproval compliance activities were completed.• Ensured product post-marketing approval, advertising, and promotional items were compliant to regulatory requirements.• Oversaw regulatory aspects of business relationships to ensure compliance and protect corporate interests.• Provided regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance.

Education

• Syracuse University

  Bachelor of Science - BS

Skills

• Clinical Operations