Simone Walsh is an Irish Registered General Nurse and Project Management Professional with nearly 20 years of experience in research.

Simone has expertise in study feasibility and activation, with a proven track record in streamlining start‑up timelines. She is recognised for her ability to bring diverse stakeholders together, fostering meaningful and effective communication that keeps studies progressing smoothly and efficiently.

Simone provides clear regulatory sign‑posting for companies, guiding sponsors through research ethics and regulatory requirements for medical devices from concept to market.

She specialises in developing Patient Information Leaflets and Informed Consent materials for all age groups, ensuring clarity, accessibility and regulatory compliance. Simone leads NREC‑MD submissions on behalf of study sponsors and also reviews existing applications to ensure they meet required ethical, regulatory and quality standards.

Simone provides training and certification for Good Clinical Practice (GCP) Medical Device, in accordance with ICH GCP (R3) and ISO 14155:2020, supporting research teams in maintaining regulatory compliance.

Approachable, detail‑focused and committed to quality, Simone brings a unique blend of clinical knowledge, regulatory insight and strategic project management to every study she supports.

Simone is an active contributor to the Irish healthcare research ecosystem and a member of:

• National Research Ethics Committe for Medical Devices

• Irish Health Research Forum

• National Clinical Trials Oversight Group

• Irish Research Nurses and Midwives Network

• Department of Health Expert Review Body on Nurses and Midwives Recommendation Implementation Group