Quality Systems and Regulatory Manager (Maternity Cover)

Privacy PolicyJob Openings Quality Systems and Regulatory Manager (Maternity Cover)QA/RA - Galway, Galway (Hybrid)Shape the Future of Cancer Treatment at Luminate Medical At Luminate, our mission is to make cancer care more human.   Our first two products, Lily and Lilac, are revolutionary wearable devices designed to address hair loss and peripheral neuropathy respectively - two of the most common and difficult side effects of cancer treatment. We have an exciting pipeline focused on building products that help cancer patients to live, not just survive. Lotus, our latest solution is a next-generation system designed to make at-home cancer care more accessible and efficient for both patients and clinics.   We’re looking for a Quality Systems and Regulatory Manager (Maternity Cover) to support our medical device portfolio on a fixed-term maternity cover contract starting August 2026. This is an exciting opportunity to be part of a multi-award-winning team and play a decisive part in the development and production of life changing devices. Above all, you will need to enjoy working in a fast-paced environment, be passionate about working with people, and thrive in taking responsibility for delivering projects on-time to make a real-world patient impact.   Working at Luminate Medical This is a key early hire at a rapidly growing company. You will have an opportunity to shape the development of multiple high-impact patient-facing products and gain first-hand insights into the growth of a start-up. We offer a highly competitive salary comparable with multinational medical device companies, a flexible benefits package (including health insurance and pension), alongside a company laptop, headphones and camera. We believe in quality of life in our products and for our people, and offer flexible working hours, and a generous vacation policy.   What You Will Do: Support the introduction of new quality initiatives, projects and new product introductions as required. This position supports delivering high-quality, compliant, and effective products to the market while adhering to applicable industry and regulatory standards.  Lead preventive and corrective actions taken in relation to product and Quality system deficiencies and initiate, recommend, or provide solutions to product and Quality system-related problems.  Interface with other departments to ensure that Quality system requirements are adhered to.  Provide reports/information to management on quality-related issues and define and implement solutions to quality-related issues.  Deliver and/or manage projects assigned and work with other stakeholders both internally and externally to achieve desired results.  Should have the ability to challenge the status quo and drive continuous improvement.  Responsible for assessment of device & process changes for regulatory implications and ensures continued compliance with regulatory agency approvals.  Leads the preparation and submission of regulatory applications.  Provide technical guidance and regulatory training/mentoring to cross-functional teams.  Act as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding submission strategy/regulatory pathway development, testing requirements, clarification, and follow-up of submissions under review.  Acts as a core member, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.  Lead or compile all materials required in submissions, license renewal, and annual registrations.  Recommend changes for labelling, manufacturing, marketing, and clinical protocol/ evaluation reports for regulatory compliance.  Supports Quality System and audit readiness through maintenance and provision of regulatory information to Quality Assurance, Notified Bodies, Competent Authorities, and FDA.  Research competitive product regulatory approvals and...