Ciara Horrigan
Regulatory Manager @Hormona
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WORK HISTORY
Regulatory Manager @Hormona
London, GB
Regulatory Strategist, Quality Management Representative and EUDAMED appointed PRRC- Regulatory oversight of all content related to wellness and/or medical products and services- Ensures Alignment to UK, EU and US women’s health strategies- Seeks strategic research partnerships & funding opportunities through grant writing, achieving £100k in grant funding from Innovate UK\'s Biomedical Catalyst Fund- Responsible for ensuring regulatory compliance of our products to EU GDPR, EU GPSR, EU AI Act and medical device products to EU MDR 2017/745, EU IVDR 2017/746, 21 CFR 80•••99 and ROW laws- Collaborating with technical team to implement IEC 62304, IEC 62366, and ISO 27001 design and development, manufacturing, data analysis, cybersecurity, medical advisory, nutrition, fertility and commercialisation specialist SMEs- Implementation & Maintenance of ISO 13 485 QMS- ISO 14971 Risk Management Certified- Engaging with external consultants- Planning Performance Evaluation studies, scientific and ethical submissions
EDUCATION
Technological University of the Shannon
Postgraduate Certificate, Regulatory Affairs & Quality
University of Bristol
MSc, Reproduction & Development
Maynooth University
BSc (Hons), Biological & Biomedical Sciences
Newbridge College
Leaving Certificate, High School/Secondary Diplomas and Certificates
SKILLS
ABOUT CIARA HORRIGAN
Regulatory Manager @ Hormona | On a mission to provide women with the tools and information they need to take control of their hormone health, by using technology driven solutions, to close the gender data/ female health research gap that affects us all.Previous Regulatory consulting experience as a Regulatory Associate (IVD/CDx medical devices),providing regulatory compliance consulting and medical writing services to clients for global regulatory requirements. Specialist in EU IVDR performance study applications/ PMS / GSPR / IVDD to IVDR Gap Analysis, and US IDE Regulations part 812, and 820 design controls, worldwide sample collection and testing site country requirements, IDE progress reports, and Regulatory Strategy report writing for EU & US.Professional in the research and development of IVD and CDx immunoassays in GCP and GMP laboratories, compliant with EU ISO regulations, with over 8 years experience in diagnostics.BSc. Biomedical Sciences, from Maynooth University, graduated, with a 2.1, in 2017. MSc. Reproduction and Development, from University of Bristol, with merit, in 2020. PG. Certificate in Regulatory Affairs & Quality Compliance Auditing from Limerick Technological Institute, with a 1.1 in 2023.ARCS Member.GCP Certified.ISO 14971 Training Certified
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