is Senior Executive with Irish Medtech 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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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.
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.
Senior Executive, Irish Medtech Association, QA/RA Forum Lead
Associate Director RA I lead the Regulatory Affairs Team in BD Enniscorthy
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.
Petra directs MedTech Europe’s team focusing on implementation and reform of the EU regulatory systems for medical devices and in vitro diagnostic medical devices (IVDs). She represents MedTech Europe to external fora on strategic regulatory policy questions, including the Medical Devices Coordination Group. She acts as part of MedTech Europe’s leadership team, ensuring collaboration and coherence on topics which cross over to other areas in the medical technologies’ ecosystem. Petra also coordinates MedTech Europe’s Neuromodulation Sector Group, a business leaders group active in manufacturing devices for areas including brain health and pain management.
Since Petra joined the association (previously EDMA, now MedTech Europe) in February 2012, her work has included leading and representing the association on regulatory policy in various domains including on implementation of the MD Regulation and IVD Regulation, CE-marking topics, device labelling, trade in animal by-products, European database, medtech standards, and regulation of substances and electronic devices, amongst others.
Before MedTech Europe, Petra worked for the American Chamber of Commerce to the EU (AmCham EU), where she headed up the policy team working on both legislative and regulatory issues. She also worked within the government affairs team of Genzyme. As an American-German national raised in Denmark who has lived many years in Belgium, Petra is a native English speaker with various knowledge in Dutch, Danish, German and French
Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and has been the Direct of Medical and Head of Notified Body at NSAI since June 2025. She is involved in developing NSAI’s service offering, taking into consideration the unique position of NSAI to promote Irish MedTech.
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A seasoned Environment, Health & Safety Product Steward with extensive experience in the Medical Device and In Vitro Diagnostics (IVD) sectors. Expert in chemical regulations, and a strong advocate for sustainable outcomes across the industry. Joined Abbott in February 2004. Holds a Postgraduate Degree in Environmental Engineering from Trinity College Dublin
Earned a BSc (Hons) in Occupational Safety & Health from Sligo Institute of Technology.
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).
Shauna Coen is a Senior II Strategic Regulatory Affairs Specialist at Aerogen Ltd., where she leads global regulatory strategies for Aerogen’s drug delivery technology portfolio. With over a decade of experience in the medical device industry, she has developed strong expertise in global regulatory frameworks, with particular focus on the EU and US markets.
Previously, Shauna served as Regulatory Affairs Manager at iThera Medical in Munich, advancing novel optoacoustic imaging technologies from research to routine clinical use. Earlier in her career, she worked with Boston Scientific Galway, supporting regulatory submissions for Class III combination products and cardiovascular devices.
Shauna holds a first-class Bachelor of Honours degree in Forensic Science and Analysis from GMIT, and two first-class honours Master’s degrees — an MSc in Regulatory Affairs and Process Validation (Medical) from TUS Limerick, and an MSc in Quality from ATU Sligo. She also lectures in Medical Device Biocompatibility and serves as a Research Supervisor with Griffith College, guiding postgraduate research in medical device technology. She has held a similar research supervisory role with the University of Lübeck during her time in Germany.
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.
Nathan Van Sweden is a Senior Director, Global Regulatory Affairs in Stryker’s corporate Global Quality, Regulatory, and Clinical (GQRC) group and is based in Cork, Ireland. In his current role, Nathan is responsible for enabling market access to our global markets through a clear and scalable global regulatory strategy. He also leads Stryker’s EU MDR and UK CA programs.
Nathan has been in the regulatory affairs field for over 20 years. During this time, he’s held leadership roles in Europe, China, and the United States. He joined Stryker in 2014 and has served in regulatory positions in manufacturing (Craniomaxillofacial division), commercial (Stryker Europe), and Corporate (Global RA). Prior to his current role, Nathan served as the PRRC for Stryker’s EAR (European Authorised Representative).
Nathan served in the US Navy prior to receiving his degree from Eastern Michigan University. He also completed the RAPS Executive Development Program at the Kellogg School of Management.