The successful candidate must demonstrate deep working knowledge of applicable FDA, ISO, and international quality and post-market requirements; strong analytical, problem-solving, decision-making, and organizational planning capabilities; sound judgment in risk-based decision-making; ability to communicate effectively with executive management, regulatory authorities, technical teams, and stakeholders; and ability to manage multiple complex priorities and deliver results in a fast-paced, highly regulated environment. PREFERRED JOB REQUIREMENTS Education An advanced degree in a relevant scientific, engineering, healthcare, regulatory, or business discipline and experience Certification / Licensure Certified Manager of Quality/Organization Excellence (ASQ CMQ/QE) Work Experience 15 years of experience in leading globally distributed teams with complaint handling, investigations, regulatory reporting, corrections and removal, regulatory authority communications, and regulatory inspections or notified body audits is preferred.