Benjamin Meany is Manager for Digital, Software and AI Regulation at MedTech Europe, covering areas including medical device software, cybersecurity and artificial intelligence, and the regulatory interplay between MDR/IVDR and digital legislation. In recent years, he has worked closely on a range of digital policies, including EU and international digital policy and emerging technological issues, such as AI and data governance. Prior to his work in Brussels, he worked in the Houses of the Oireachtas, advising on social and health access policies.
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Niall is the Director of Medical Devices at the Health Products Regulatory Authority (HPRA) in Ireland. As a member of the HPRA’s leadership team, he is responsible for the operation and development of HPRA’s regulatory activities and capabilities for medical devices and leadership of its Medical Device Department. His work over the next number of years will focus on ensuring effective operation and consistent application in practice of the new EU Regulations on medical devices and optimising the HPRA activities for medical devices.
Niall MacAleenan qualified as a medical doctor at Trinity College Dublin in 1999. Niall worked in a variety of clinical and research roles across the Irish health care system. He also attained a business degree from University College Dublin. Since joining HPRA Niall has held a variety of different roles at senior level within the organisation both in the area of medical devices and human medicines. In 2018, Niall was appointed as the Head of Medical Devices to design, establish and lead the HPRA’s new medical devices department and the development of our team and activities to ensure HPRA is ready to apply the new EU Regulations in practice.
Niall is a leading European expert on medical devices. He represents HPRA and Ireland at the EU Medical Device Coordination Group (MDCG), the EU Regulatory Committee, the Executive Group of the Competent Authorities for Medical Devices (CAMD) network and, when required, at the European Council’s Working Party on Pharmaceuticals and Medical Devices. Niall is also a member of the European delegation to the Management Committee of the International Medical Device Regulators Forum (IMDRF).
niall.macaleenan@hpra.ie
Mairead Twomey is a Senior Director Regulatory Affairs for Stryker (based in Cork, Ireland). In Mairead’s role, she leads regulatory affairs for the Instruments Division across a broad product range and portfolio of products across all product classifications.
Mairead joined Stryker in 2005 and has had multiple roles across Operations, Quality and Regulatory. In her current role, Mairead is responsible for leading the global regulatory affairs team in developing and implementing regulatory strategies and global submissions for various medical devices. As part of her role, she interfaces with various global regulatory bodies, including FDA, Notified Bodies and multiple Competent Authorities.
Mairead earned her BSc in Physics and Physics Technology from D.I.T, Dublin and is a member of RAPs. Mairead is an active member of the Irish MedTech Association Regulatory Steering Committee, is also involved in the European MedTech Association and guest lectures on the topic of regulatory affairs at UCC.
Nicola is the Regulatory and Policy Manager within the HPRA Medical Devices Department. Her role involves policy development, stakeholder engagement, market analysis and support to the regulatory functions of the HPRA devices department. Nicola is also a delegate of the Medical Device Coordination Group (MDCG) working with EU colleagues and stakeholders towards a harmonised implementation of the device regulations in the EU.
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Dr Emer Sherry is Senior Executive with Irish Medtech Association since May 2022 leading the regulatory affairs workstreams including the QA/RA forums and the Task Forces. Prior to joining IMA, she held senior positions in Telecommunications Industry Ireland and Audiovisual Ireland within Ibec overseeing the regulatory affairs and public policy work streams. She represented industry on the Government’s Task Force on Mobile Phone and Broadband. She continues to lead the 5G work stream within Ibec. Emer is an active member of Medtech Europe’s MD and IVD Regulatory Affairs Committee. She holds a first-class honours degree in electronic engineering and a PhD in the same discipline from University College Dublin.
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As Associate Director RA I lead the Regulatory Affairs Team in BD Enniscorthy. Currently supporting numerous projects across EU Medical Device Regulation remediation & implementation, International Registration, New Product Development & UDI activities.
I have over 18 years’ experience in Regulatory Affairs, working in the medical device field for the last 11 years.
Eileen is a Senior Regulatory Affairs Manager with Abbott Vascular and is responsible for developing and implementing regulatory strategies and global submissions for medical devices with a particular emphasis on class III drug eluting stent products. Prior to joining Abbott Vascular, Eileen worked in pharmaceutical regulatory affairs with Acorn Regulatory Consultancy Services and Roche Product Ireland Limited. She worked in technical services in Abbott Diagnostics. Eileen holds a B.Sc in Biotechnology from DCU and a PhD in Cellular Biology from Trinity College Dublin.
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Danica is a Regulatory Affairs Specialist at Medtronic, primarily focused on post-market activities aimed at maintaining products on the global market. Experience leading and supporting EU MDR submission filings with notified bodies for a range of devices including class III devices and drug-device combination products. Danica supports global regulatory product change control, submissions for product changes and country renewals. Experience with submission filings in major markets such as Japan and Canada. Experience in the creation and maintenance of drug-device combination product Drug Master Files for EU, US and Singapore. Danica holds a B.Sc in Human Nutrition from ATU Sligo and an M.Sc in Biomedical Science from NUIG.
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Paul has worked for Boston Scientific for 23 years, prior to that he worked in Abbott Diagnostics and Biolabs Europe. At Boston Scientific, Paul is a member of Global Regulatory Operations team and has responsibility for Notified Body relationship management at a Corporate level, which encompasses 3 key notified bodies. He is also Regulatory workstream lead for Corp MDR project in Boston Scientific. Prior to these roles, he worked as a Reg Specialist and Manager supporting Boston Scientific Drug eluting stent and balloon products. Paul as a B.Sc Toxicology from A.I.T, H.Dip Microbiology from UCG, and Master in Project Mgt from UL.
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• Leader within Merit, responsible for sites in Ireland and France.
• Responsible for US and EU device regulations including implementation of MDR.
• Member of the Irish MedTech RA Steering Committee.
• Qualifications include a Masters in bioengineering.
• Previous roles with industry in Ireland, UK and Germany including a Notified Body.
Róisín is a Senior Regulatory Affairs Manager (Pre-Market) in Veryan Medical and has worked for Veryan Medical since 2010 being heavily involved in achieving PMA approval, CE Mark approval and Shonin approval for its peripheral stent product. She has over 25 years of experience in the medical device and pharmaceutical industries across regulatory affairs, design assurance, clinical evaluation, quality systems, & project management in the development of high-risk Class III cardiovascular devices and combination products in start-up and multinational organisations.
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Dr Ann O’Connell PhD is a visionary leader, a dynamic collaborator. As Head of Funded projects for Medtech and Engineering Skills with Ibec, Ann is responsible for funding, development and delivery of over 100 professional upskilling programmes ranging from 1-day webinars, to 2-year Masters programmes. Ann’s course list is wide ranging and comprehensive, covering Research & Development, Manufacturing & Digitalisation, Quality & Regulatory, Sustainability, and Management & Leadership, and she specialises in piloting and launching new programmes to meet emerging needs.
Ann completed her PhD in 2014 with the Centre for BioNano Interactions (CBNI) at University College Dublin and is a longtime advocate for lifelong learning amongst industry professionals. She joined Ibec in 2019 from Irish Manufacturing Research Centre, where as the European Programme Manager, she refocused strategy and investment and led the successful application of a proposal to coordinate a H2020 funded project under the ECSEL JU Program. Prior to that, Ann served as Senior Integration Engineer with Intel Corporation for almost two decades, supporting multiple business sectors across diverse geographies, Ann’s deep understanding of the power of technology, digitalisation, data science and intelligent automation in advancing all businesses is applied with expertise and purpose in her role today, as she supports the industries that will solve some of the world’s most critical health and environmental challenges.
“Knowledge is power, and we should never stop learning - especially as the challenges facing our world grow increasingly urgent. The knowledge we build today will trigger the discoveries of tomorrow, to empower solutions for our future”.
Tommy McDonagh is an Associate Director of Regulatory Affairs, IVDR at Abbott Core Diagnostics (based in Sligo Ireland).
Tommy joined Abbott in April 2005 and has held multiple roles across Quality, Technical Operations and Regulatory. In his current role he leads the IVDR transition Program for the European Manufacturing sites across a broad portfolio of products across all IVDR product classifications.
As part of his role, he interfaces with various regulatory bodies, including Notified Bodies and multiple Competent Authorities. Tommy is an active member of the Irish Medtech Association (IMA) IVD Task Force supporting the IMA QARA Forum and a member of the IMA Regulatory Steering Committee.
Tommy holds a Master’s degree in Biomedical Science from the University of Ulster – Coleraine in Northern Ireland and a Bachelor of Science in Microbiology from the University of Galway, Ireland. He also holds a Project Management Professional (PMP) certification.
Elaine O'Connor is Director of Regulatory Affairs at Medtronic's Centre of Excellence for Operations and R&D in Parkmore Galway, Ireland. Elaine has worked in the medical technology industry for over 20 years with experience spanning US, EU and emerging markets. In her current role, Elaine leads a regulatory team (based primarily in the US and Ireland) involved in the development and implementation of regulatory strategies and global submissions. As part of her role, she interfaces with various global regulatory bodies, including FDA and multiple Notified Bodies.
Her educational journey includes a BSc in Microbiology from UCC, an MSc in Biotechnology from NUI Galway, and a Higher Diploma in Quality Assurance from NUI, Galway. With a specialized focus on high-risk cardiovascular devices, catheter-based technologies, and drug-device combination products she has been actively involved in advocacy forums focused on the development of streamlined regulatory submissions, to promote timely regulatory approvals that benefit the patients we serve.