Design Assurance Manager Galway Role Summary The Design Assurance Manager is responsible for ensuring medical devices are designed and developed in compliance with applicable regulatory requirements and quality standards. This role provides leadership across design controls, risk management, and verification and validation activities throughout the product lifecycle, while partnering closely with cross-functional teams. Key Responsibilities Own and maintain design control processes in compliance with ISO 13485, EU MDR, and FDA 21 CFR 820. Ensure complete and compliant Design History Files (DHF) and design documentation. Lead risk management activities in accordance with ISO 14971. Oversee design verification and validation, including usability engineering where applicable. Support design transfer to manufacturing and related validation activities. Provide design assurance input to design changes, CAPAs, complaints, and post-market activities. Support regulatory submissions and audits (Notified Body, FDA, internal). Qualifications & Experience Bachelors degree in Engineering, Science, or related field. 5+ years experience in design assurance, quality, or regulatory roles within the medical device industry. Strong working knowledge of ISO 13485, ISO 14971, EU MDR, and FDA design controls. Experience supporting audits and regulatory submissions. Key Skills Strong attention to detail and documentation skills Effective cross-functional communication Risk-based decision making Ability to work independently in a regulated environment