Claire is a Principal Regulatory Affairs Specialist at Bausch & Lomb in the UK and Irish affiliate and has been specialising in UK Medical Devices Regulation since the UK left the EU in 2020. She has implemented the requirements of the UK Medical Devices Regulations 2002 across the business alongside administrating Bausch + Lomb’s UK Responsible Person office. In addition Claire is the current Chair of the PAGB Medical Devices Working Group and providing support and industry insights to PAGB to assist them in responding to UK government consultations.
Prior to joining Bausch and Lomb Claire worked in medical device R+D and at the MHRA in adverse incident investigation and then as manager of the medical devices compliance unit. This experience has helped her interpret, navigate and challenge the existing and proposed changes within UK medical device regulation.
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.
Sheila Walsh is Associate Head of Clinical Compliance at BSI. She holds an Honours Degree in Biomedical Engineering and started her career in the medical device industry focusing on the manufacture of cardiovascular devices. She then moved into a clinical research-based role, where she was responsible for the conduct of clinical studies.
Sheila joined BSI in 2007 and has over 18 years Notified Body experience conducting various roles including Technical Specialist, Clinical Evaluation Specialist and Decision Maker. Sheila joined the BSI Global Regulatory Compliance team in 2022 and is currently responsible for providing clinical regulatory support to BSI’s Internal Clinician’s and Operational Teams. Through her experience with the Notified Body combined with past industry and clinical experience, Sheila has gained extensive knowledge of the Medical Device Directive and Medial Device Regulation with a particular interest in the clinical aspects of conformity assessment.
Chief Specialist, Corporate Quality at Stryker. Fidelma has responsibility for creation, implementation, and maintenance of global quality system processes across Stryker divisions. She was the lead for implementation of the revised ISO13485 in 2016 and is currently leading the QMSR transition for all impacted quality systems within Stryker.
Ms. Sheerin has served within the Medical Device & Pharma industry for over 30 years. She has fulfilled roles in quality control, quality assurance and been involved in QMS set up/ creation within new startup companies.
She lives in Limerick, Ireland with her husband, John and daughters, Sarah and Rebecca. When not at work, she likes to spend her free time cooking, hosting parties, hiking / walking, gardening.
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
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
Padraig has more than 35 years’ experience across a variety of engineering and management roles in areas including semiconductor engineering, software development, quality management and medical device regulatory affairs. At S3 Connected Health he leads the Quality & Regulatory Affairs team with responsibility for S3 Connected Health’s quality management system and all aspects of regulatory compliance. S3 Connected Health’s 200-strong multidisciplinary team throughout Europe and the US have delivered award-winning solutions for customers in pharma and medtech for over 20 years. This combination of experience and innovation allows S3 Connected Health to provide impactful digital health solutions that truly transform healthcare.
Padraig works with S3 Connected Health’s customers to develop digital health solutions and connected medical devices, and to define appropriate regulatory pathways for market access. He has expertise in regulation of Software as A Medical Device (SaMD) and related standards including IEC 62304, IEC 82304-1, ISO 14971, and IEC 62366-1.
Padraig earned his degree in Electronic Engineering from the National University of Ireland, Galway
Toma has experience in the medical device industry, digital health technologies, regulatory affairs, and quality, including a bachelor’s degree in Business from University College Dublin and an MSc in Medical Device Regulatory Affairs from South East Technological University.
Toma most recently worked with Ocumetra as a Regulatory Affairs and Market Access Officer, before joining Irish Medtech as an Executive. Other than that, Toma has nursing background and experience working in variety of healthcare settings both in Ireland and abroad.
Jennifer McCormack leads the Connected Health Skillnet, an industry-led learning and development network established to address the skills needs arising from the convergence of the medtech, pharma and technology sectors in digital health. Jennifer works closely with industry and education partners to develop and deliver training initiatives and cross-sectoral knowledge sharing events focussed on digital health. She also oversaw the development of Irelands first ecosystem map, skills needs analysis and skills framework for Digital Health.
Since 2018, Connected Health Skillnet has engaged with over 250 companies across the medtech, pharma, technology, and digital health sectors to upskill 2000+ trainees in key areas including medical device software, quality and regulatory, cybersecurity, needs-led innovation and leadership development. The Networks objective is to enhance the capability of Ireland and Irish based companies to become leaders in the development and commercialisation of digital health solutions by building a world class, multi-disciplinary talent base to support the sector.
Dr. Simon Rowan is the Medical & Clinical Affairs Manager with Aerogen Ltd. His academic training is in chronic respiratory disease with publications in the leading medical journals in his field including the Lancet Respiratory Medicine & Circulation and a patent in the field of lung transplantation. He holds a Phd in Translational Medicine from UCD & was awarded a Global Maria Skłodowska-Curie Fellowship in Medicine during which he worked under Prof. Paul Noble in Cedars-Sinai Medical Centre LA, USA. He was an Assistant Prof. of Physiology in the UCD School of Medicine. In Aerogen, among other activities, he is responsible for clinical evaluation strategy & execution for all products as well as PMCF.
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Laura is a Sr. Regulatory Affairs Program Manager at Medtronic based out of Galway site, with primary focus on post market activities. She has over 22 years’ experience in the medical device industry, working in regulatory affairs for the last 17 years. She has held roles as the RA Core Team member for the Coronary and Renal Denervation Operating Unit’s EU MDR Program, and is now involved in OU projects related to PFAS changes, leading the regulatory strategy in global markets. She holds a BSc degree in Industrial Biochemistry from the University of Limerick.
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