Robbie is a Director of Regulatory Affairs in Boston Scientific, based in the Galway office and has worked in the medical device industry for over 20 years, with many years of experience in senior quality and regulatory management roles. Previous to Boston Scientific, he worked in a variety of multinational medical device companies in the respiratory care area along with some time in a start up company, headquarted in Galway, in the ventilation field.
At Boston Scientific, Robbie has responsibility for regulatory activities in the Structural Heart valve space which include development and execution of regulatory strategies and subsequent submissions on a global basis. At a broader Interventional Cardiology (IC) level, he plays a leading role in the management of the Boston Scientific Notified Body strategy and relationship and is currently overseeing regulatory execution of EU MDR across IC.
From an academic perspective, Robbie has a BSc in Electronic Engineering and an MSc in Reliability Systems, both from the National University of Limerick. He is a member of the Irish Medtech Association Regulatory Steering Committee and is currently Chair of the Irish Medtech Association Quality & Regulatory Forum.
John Kilmartin is Vice-President of Regulatory Affairs in Medtronic (part of the Coronary and Renal Denervation OU). John has worked in the medical technology industry for many years with particular emphasis on US, European and emerging market regulatory frameworks.
He has a particular interest in high-risk Class III cardiovascular devices, catheter based technologies and combination products. In addition, he has a strong interest in the evolving regulatory frameworks that continue to develop across the globe.
In his current role, John leads a global regulatory team of over 50 people (based primarily in the US and Ireland) involved in the development and implementation of regulatory and clinical strategies and global submissions for various medical technologies and combination products.
John is involved with various industry associations on regulatory developments and is currently a member of the Irish Medtech Association, Regulatory Steering committee.
Olga van Grol-Lawlor is a seasoned Regulatory Affairs Professional with over a decade of experience in the medical devices sector. Olga joined Boston Scientific in 2016 supporting the EMEA (Europe, Middle East and Africa) region before moving to Boston Scientific’s Corporate organisation as the Global Regulatory Intelligence and Advocacy Manager. Olga has been involved in various MedTech Europe working groups since 2016 and represents Boston Scientific on the Regulatory Affairs Committee. She is a MedTech Europe EUDAMED and UDI working group core team member and has served as one of the industry representatives on the EUDAMED Actor Registration working group with the European Commission. She chairs the Irish MedTech Associations Authorised Representative, Economic Operator and Supply Chain task force and participates in various industry associations including RAPS, Advamed, MDMA, and the GS1 Healthcare Public Policy group. She is a regular speaker in educational conferences on regulatory topics including EUDAMED and the EU Medical Device Regulation. Olga worked for Medtronic prior to moving to Boston Scientific and worked in the field of Equine Science prior to moving to medical devices. She holds a BSc degree in Equine Science and an MPhil research degree in Equine Endometrial Cytology and Bacteriology.
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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.
Senior Director, Regulatory Affairs, Europe. Mark is a Leader within Merit, responsible for sites in Ireland and France. He is responsible for US and EU device regulations including implementation of MDR. He is a member of the Irish MedTech Regulatory Affairs Steering Committee and leads the Irish Medtech Association Clinical Evaluation Task Force. Qualifications include a Masters in bioengineering. He has held previous roles with industry in Ireland, UK and Germany including a Notified Body.
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
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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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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John is a Medical Doctor with extensive experience in the healthcare sector including general Medical professional training, Anaesthesia training and broad research experience. He was previously Medical Director and European Manager of NSAI (Notified Body) with responsibility for overall clinical approvals of CE Mark certifications, where he worked closely with many EU Competent Authorities and with the European Medicines Agency (EMA) with drug-device reviews. As Medical Director EMEA for Teleflex Medical, he is responsible for providing clinical input into all risk-based activities, ensuring accurate medical oversight and compliance with EU MDR and with international regulatory and marketing requirements. He has responsibility for Clinical Evaluations & Investigations, Post-Market Surveillance, Risk Evaluations and he works with R&D identifying unmet clinical Need opportunities working with KOLs and providing clinical input into New Product Development. During his clinical career in Medicine he completed a Master’s degree in Medicine, and during his Medtech career as Medical Director he completed a Master’s degree in Business Administration
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Nate Van Sweden is a Director, Regulatory Affairs in Stryker’s corporate Global Quality, Regulatory, and Clinical (GQRC) group. In his current role, Nate leads Stryker’s EU MDR and UK CA programs and is responsible for partnering with internal stakeholders to deliver solutions that aid in faster global market access.
Nate has been in the regulatory affairs field for nearly 20 years. During this time, he’s held leadership roles in Europe, China, and the United States. Nate joined Stryker in 2014 and has served in regulatory positions in manufacturing (Craniomaxillofacial division), commercial (Stryker Europe), and Corporate. Prior to his current role, Nate served as the PRRC (Person Responsible for Regulatory Compliance) for Stryker’s EAR (European Authorised Representative).
Nate has worked with various global industry associations during his career and is currently active in MedTech Europe and Irish MedTech Association working groups/task forces.
Nate served in the US Navy prior to receiving his bachelor’s degree from Eastern Michigan University.
Danica is a Regulatory Affairs Specialist at Medtronic, primarily focused on post-market activities aimed at maintaining the company's products on the global market. She has been instrumental in supporting Medtronic's EU MDR submission filings and MDR implementation related to various medical devices, with a particular emphasis on class III devices. Danica holds a B.Sc in Human Nutrition from ATU Sligo and an M.Sc in Biomedical Science from NUIG.
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Karen Hyland is a Director of Regulatory Affairs at Medtronic's Centre of Excellence for Operations and R&D located at Parkmore Galway, Ireland. With over 15 years of experience in the medical device industry, Karen leads a diverse team responsible for developing and implementing global regulatory strategies, including EU MDR, for various medical device and combination products.
Karen graduated with a Bachelor of Science degree from the National University of Ireland, Galway and later earned a Master of Science degree from the University of Ulster. Throughout her career, Karen has developed a keen interest in the evolving regulatory frameworks and recognises the role of regulatory affairs in providing strategic leadership to influence the global regulatory environment for the benefit of patients.
Liz leads the Regulatory Affairs Team in BD Enniscorthy currently supporting numerous projects across EU Medical Device Regulation remediation, International Registration, New Product Development & UDI activities.
She has over 17 years experience in Regulatory Affairs, working in the medical device field for the last 10 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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Una Barry has 15 years’ experience working in Post Market Vigilance in Stryker, her more recent focus is on setting up the Post Market Surveillance process for the Stryker Instruments Division. Una is currently the chair of the PMS and Vigilance Taskforce for the Irish MedTech Association.
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Ian Phillips is a Senior Regulatory Affairs Manager in Boston Scientific. Ian supports the Structural Heart business managing a team of regulatory professionals based globally (Brazil, Switzerland & Ireland). Ian is with Boston approximately four years having previously held Regulatory and Quality roles in Medtronic and Technical Operations roles in Abbott Diagnostics and Trinity Biotech. Ian holds a B.Sc. in Analytical Science from Dublin City University and is currently completing a M.Sc. in Regulatory Affairs (ATU Sligo/University of Galway) as part the Skillnet program.