University Bridge Fund

About NeuroBell:

NeuroBell is a medical device company headquartered in Cork, Ireland, developing innovative solutions for improved brain monitoring for newborns. 0.5% of all newborns suffer brain injury and require brain monitoring to guide diagnosis and treatment to ensure the best possible outcome.

NeuroBell was initially funded through the Enterprise Ireland Commercialisation Fund programme and supported by +10 years of translational research at the INFANT Centre, University College Cork. NeuroBell has raised €1m in grant funding and €2.1m in Seed funding in 2023 led by two Venture Capital firms (Furthr VC and Atlantic Bridge). NeuroBell’s Cork office has +10 staff across commercial, scientific, engineering (hardware, firmware, software, and AI), clinical, and quality roles.

NeuroBell’s flagship product is the NeuroBell Luna, a pocket-sized & wireless electroencephalography (EEG) monitor for use by all Neonatal Intensive Care staff, which provides automated on-board seizure detection and a cloud-based web application for easy medical review and reporting. NeuroBell Luna is currently in clinical trials across Ireland and the US, with an FDA 510(k) submission planned in 2025.

About the Role:

NeuroBell is looking for a Director of Quality and Regulatory Affairs to become the next key person in its leadership team. You will own and shape the Quality and Regulatory Affairs functions at NeuroBell:

• Overseeing the maintenance and implementation of an ISO13485-compliant Quality System;
• Supporting R&D colleagues in Design History File and Device Master Record documentation;
• Supporting the development of submissions for market approval in the US and Europe;
• Supporting both internal and external audits/inspections;
• Participate as a key part of the senior leadership team, providing input to company strategy, and the long-term goal of developing market-leading solutions for neonatal brain monitoring.

About the Candidate:

The ideal candidate will be a keen problem-solver and eager to work alongside R&D colleagues in product development and clinical affairs. They must have clear attention to detail, enjoy fast-paced working environment, and thrive in taking responsibility for the development of effective products.

Requirements:

• Expert knowledge of ISO 13485 and ISO 14971, and leading compilation of Design History File (DHF) and/or Technical File documentation, as per US and EU regulations;
• Direct experience of implementing a QMS for medical device design and development;
• Experience in completing regulatory submissions of medical devices through EU and/or FDA;

Advantages:

• Direct experience in leading the regulatory submission through FDA 510(k) clearance;
• Experience with IEC 60601: electrical medical devices and corresponding verification testing;
• Experience with IEC 62304: medical device software and corresponding documentation;
• Experience with IEC 14155: clinical investigation of medical devices and GCP.

Responsibilities:

• Lead the FDA 510(k) submission via eSTAR Program for a Class II medical device;
• Contribute to ongoing ISO 13485 audits and lead the accreditation/maintenance of the QMS;
• Lead the preparation of the Technical File for MDR Conformity Assessment via Annex IX;
• Oversee the quality and documentation for both MDR Article 62 and FDA IDE clinical studies.