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. Additional beneficial experience includes responsibility across multiple product types or jurisdictions and working knowledge of risk management, design controls, manufacturing controls, validation, supplier controls, clinical or patient risk assessment, quality system records, and enterprise systems used to support investigation, traceability, and corrective action activities.