Dario Belluomini is Manager International Affairs at MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices, and digital health.
In this position, he manages and coordinates projects and working groups addressing market access, trade policy initiatives and international regulatory matters in the medical technologies sector, with a primary focus on the countries outside of Europe. He is involved in the association’s work to map the impact of EU MDR/IVDR on international registrations and the global efforts to promote regulatory convergence and reliance to accelerate access to medical technologies.
He is experienced in representing the organization before multiple institutional stakeholders as well as engaging with third country authorities and international fora (e.g., IMDRF, GMTA).
Earlier in his career, he coordinated market trackers and ad hoc market intelligence projects in the medical technologies sector. He holds a Master’s Degree in International Trade from the University of Antwerp (Belgium).
• Chair of Irish Medtech Regulatory Steering Committee
• 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.
Mairead Twomey is Chair of the Irish Medtech QA/RA Forum and 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 & Policy Manager for medical devices in the HPRA. Her role involves supporting policy development on regulatory issues at national and EU level and is also responsible for stakeholder engagement on regulatory issues. Nicola is a delegate of the Medical Device Coordination Group (MDCG) working with EU colleagues towards application of the device regulations in the EU.
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Associate Director, Regulatory Affairs leading the Regulatory Team in BD Enniscorthy. Currently supporting numerous projects across EU Medical Device Regulation remediation, International Registration, New Product Development & UDI activities.
With over 18 years’ experience in Regulatory Affairs, working in the medical device field for the last 10 years.
Alice Forde is Director of Regulatory Affairs for Europe for Medical Devices at Bausch & Lomb. Alice has 27 years’ experience in the medical devices & pharma industry, having previously held roles in Teleflex, Medtronic, Boston Scientific, and Chanelle Pharma. This experience encompasses 10+ years in Regulatory Affairs, along with Program & Project Management. Quality systems, Vigilance, Compliance, Operations, HR, Talent Development, IT. Alice also has extensive knowledge & experience of EU MDR, Standards and US/ROW Regulations, Audits including MDSAP, Lean Sigma practitioner. Alice holds an MSc in HRD & Performance Management from the University of Leicester and a Postgraduate Diploma in Medical Device Science from the University of Galway.
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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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Paul Scannell is Senior Director with West Pharmaceutical Services and leads the European Regulatory Affairs Office with regulatory responsibilities for delivery system medical devices and combination products for European and Eurasian Economic Union (EAEU) markets.
Paul has 18 years of experience across medical device and combination product regulatory affairs gained through his work in industry, consulting, Notified Body (NSAI) and Competent Authority (HPRA).
Paul participates in a number of industry regulatory associations and task forces and is currently a member of the Irish Medtech Association, Regulatory Steering committee.
Paul has an undergraduate degree in Mechanical Engineering and a PhD in Biomechanics from the University of Dublin, Trinity College. He also holds a master’s degree in Management from University College Cork.
Bernadette works for Mylan Institutional a Viatris company located in Inverin Co. Galway for the past 17 years. Bernadette has nearly 25 years’ experience in the device and pharma industry, having previously worked for Abbott Diagnostics. In her current role within Regulatory Affairs her responsibility is for the medical devices manufactured at the site, and supporting their transition to the EU Medical Device Regulation.
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BSc. (Honours) in Pure and Applied Chemistry and MSc. (Honours) in Regulatory Affairs Medical Technology.
RA Manager in Medentech Ltd (Kersia Group) since 2018, prior to this RA Specialist in Medentech since 2012. Medentech Ltd manufacture and market disinfection products for a range of applications, including medical device disinfection, and RA manager role is responsible for all aspects including risk, clinical, biocompatibility, safety and performance.
Shane has been a Senior Regulatory Affairs Specialist with Merit Medical since March 2020, where he has worked on projects and MDR submissions guidewires intended for cardiovascular use. He has also worked in various scientific, quality, and regulatory roles with Abbott Diagnostics, Medtronic, Teleflex, Boston Scientific and Surmodics. He has been a member of the Irish MedTech Association Task Force on Labelling since September 2020. Shane has a BSc in Biotechnology from NUI Maynooth, and a MSc in Biotechnology from UCD.
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Is a senior Regulatory Specialist for Bausch + Lomb’s Vision Care business in the EU Authorised Representative and Global Regulatory Affairs functions. She also has experience in the medical devices’ distributor/ importer sector across a wide range of devices. She received her bachelor’s degree in Toxicology, and has an MSc in Medical Devices Regulatory Affairs, and a postgraduate diploma in Biopharmaceutical Regulatory Affairs.
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