Title: QA / RA Manager
Location: ATU Ihub, Dublin Road, Galway


Company:
My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body.



Role:
QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influence your work will have on the quality of life of patients. As QARA Manager you will get the opportunity to apply your knowledge in areas such as quality systems, supplier controls, design assurance, test method development and validation, design controls, and regulatory affairs during this exciting time as they bring their products to market. High paced start-up moving from Phase 2 to Phase 4 within the next 18 months working closely with our Contract Manufacturer.



Responsibilities:
- Lead and maintain Design Control processes in compliance with regulations (e.g. FDA 21 CFR Part 820, ISO 13485, EU MDR)
- Ensure robust implementation of design inputs, outputs, verification and validation
- Oversee Design History File (DHF) completeness, accuracy, and audit readines
- Drive risk management activities in accordance with ISO 14971, including FMEA and hazard analysis
- Develop, implement and maintain the Quality Management System (QMS)
- Ensure alignment between design controls and broader QMS processes
- Oversee CAPA, deviations, and non-conformance processes related to design and development
- Lead internal and external audits, including design-focused regulatory inspection
- Drive continuous improvement using quality metrics and design performance data
- Interface with regulatory authorities on design-related queries and submissions
- Mentor QA/RA and Design Assurance team members

Requirements:
- Bachelor’s Degree in Engineering, Life Sciences, or related field
- 8+ years' experience in Quality Assurance, Regulatory Affairs, or Design Assurance
- Familiarity with eQMS systems
- Extensive experience of developing and delivering effective training on Quality Systems and Processes
- Firsthand experience of audits by regulatory authorities
- Experience in hosting and leading FDA and other regulations


Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on 087 0612325 OR [email protected]