Director of Quality Assurance & Regulatory Affairs - Hybrid Galway My client, a clinical-stage medical device manufacturer, is seeking an innovative and experienced Director of Quality Assurance & Regulatory Affairs to join its senior leadership team.
As Director of QA/RA, you will own and lead the company's Quality Assurance and Regulatory Affairs strategy and execution - from development through commercial approval and post-market surveillance.
You will serve as a key member of the management team, shaping regulatory strategy, building scalable quality systems, and ensuring global compliance as the organisation advances through clinical development and commercialisation.
Key Responsibilities ? Full ownership of the QA and RA functions across all processes leading to commercial approval and post-market activities ? Act as Person Responsible for Regulatory Compliance (PRRC) under EU MDR 2017/745 ? Monitor global regulatory agency actions and proactively adapt strategy to regulatory changes ? Support development and validation of test methods ? Oversee manufacturing quality controls (inspection standards, plans, test methods, frequencies) ? Lead Quality System audit processes and ensure traceability across design stages ? Support planning and execution of clinical development programs, including: ? Ensure clinical regulatory obligations including vigilance and safety reporting ? Prepare and maintain regulatory documentation for global submissions Experience & Qualifications ? Primary degree in Science, Engineering, or a related discipline ? Minimum 10 years' experience in medical devices within Quality, Regulatory, or Design Assurance roles ? Strong experience with Class II/III cardiovascular devices preferred ? ISO 13485 Lead Auditor qualification ? Clinical trial regulatory expertise ? Extensive experience in regulatory documentation and scientific literature analysis ? Proven leadership and people management capability ? Strong analytical mindset with the ability to challenge data, identify gaps, and generate robust technical reports to support submissions If you are an experienced QA/RA leader looking to build and scale regulatory excellence within an innovative medtech company, this role offers both challenge and significant career impact.