Darren Walsh

Experience

1. Sr Director, Quality

   Edwards Lifesciences

   Apr 2022 — Present

   Lead a team of 20+, including 3 direct reports at the Director level, to spearhead transformational programs. • Provide strategic leadership to a high-performing, diversified team including Internal Audit, Archiving, Complaint Evaluation Labs, Implant Patient Registry (IPR), and Technical Writing. • Mentor and develop Quality professionals to foster an environment of inclusivity, open communication, and collaboration. • Led the company to significantly increase market share in China by navigating the complex regulatory pathway. • Proactively interface with global regulatory agencies (FDA, Notified Bodies, NMPA, etc.) to resolve issues. • Report to executive management on the performance of the Quality Management System. • Promote the awareness of regulatory requirements throughout the global organization. • Ensure that adequate resources are made available to maintain an effective Quality Management System.

Education

• University of Central Florida

  BS, Molecular Biology and Microbiology

Skills

• Fda
• V&V
• Design Control
• Ivd
• Iso
• Medical Device Directive
• Validation
• Medical Devices
• Biotechnology
• 510(K)
• Iso 13485
• 21 Cfr 820
• Quality Auditing
• R&D
• Iso 9000
• Technical Files
• Cmdcas
• Regulatory Affairs
• Iso 14971
• Regulatory Submissions
• Pma
• Capa
• Ce Marking
• Gmp
• Quality System
• Biomedical Engineering