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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Ann Hunt has worked in the Medical Device industry for over 20 years. Following completion of her PhD degree in Microbiology from University College Galway she re-located to Japan where she worked as a researcher in the Pharmaceutical Industry. On her return to Ireland 3 years later she joined CR Bard (subsequently acquired by AVE and then Medtronic) to manage the Microbiology laboratory. Over the intervening years she has managed numerous quality departments including Sterilization, Receiving Inspection, Calibrations, Operations and in more recent years Compliance and Quality Systems. As well as managing external audits for the site Ann has played a pivotal role in embedding the FDA Case for Quality Program within Medtronic. In addition she also supports Quality System activities at some of the Medtronic European sites. She sits on numerous Quality Community of Practice forums in Medtronic where she works with colleagues and stakeholders to harmonize practices across the company
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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”.
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.
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.
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.
Dr Emer Sherry 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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Nora is a Principal Regulatory Affairs Specialist for Stryker (based in Cork, Ireland). Nora is primarily focused on change assessments for orthopaedic devices and maintaining products in the global markets. Nora supports global regulatory product change control and submissions, has extensive experience with submission filings in major markets such as EU (Class III devices) and US (Class II devices). Nora holds a B.Sc in Biology and Agricultural Science, Masters in Biological Sciences and Diploma in Quality Management.
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Dr. Susan Dwane graduated with a BSc (Hons) in Biomedical Sciences from Dublin Institute of Technology, Kevin Street in 2009 and subsequently received a PhD in Biochemistry and Molecular Biology from University of Limerick in 2013. Following two years working on postdoctoral projects in Stokes Institute, University of Limerick, Susan joined Serosep, a diagnostics company based in Limerick, in 2015 as a member of the R&D team. Shortly thereafter, she moved to the Quality/Regulatory team, responsible for compiling regulatory submissions for global markets, including EU, USA and Australia.
She currently works as the Regulatory Manager for Serosep since early 2021 and is responsible for the regulatory strategies for new product development and regulatory compliance for marketed products.
Jen Lynch has recently joined the Irish MedTech Springboard team as an Executive. Jen previously worked with Biopharmachem Ireland and was involved in the development and growth of the laboratory apprenticeships throughout Ireland. With a background in marketing, Jen also recently worked as Marketing Lead for Kelly Ireland promoting workforce solutions to medtech and pharma companies in Ireland and the UK. In addition to working with Springboard, Jen will also be helping manage the Manufacturing Engineering and Polymer Processing apprenticeships.
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Fidelma Sheerin is 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.
Over 16 years of industry experience in the Medtech industry in Ireland, special focus on cardiovascular devices for multiple manufacturers.
4 years as Lead Auditor for ISO13485, EU MDR, MDSAP and UKMDR.
Local contact for TUV Sud clients and manufacturers in Ireland.
John Fegan is Director, Global QMS at Merit Medical. John has responsibility for development and implementation of key QMS initiatives within Merit’s global Quality System.
In over 25 years across the Food, Electronics and Medical Device industries, John has amassed a broad range of experience from start-ups to multi-nationals in Quality Systems, Sterilisation, New Product Introduction and as a focal point of audits by an array of Competent Authorities and Notified Bodies.
John lives in Galway, Ireland with his wife and two teenage sons. Outside of Merit, John works as a part time chauffeur (as anyone with two teenage sons who play sport will understand).
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.
Sigrid Liner joined MedTech Europe, the European trade association for the medical technology industry, in June 2023. As Director Sustainability and Environment, she leads the association’s work in this area.
Before joining MedTech Europe, Sigrid worked at the Brussels office of the Bundesverband der Deutschen Industrie e.V. (BDI), focusing on EU Green Deal policies, and spent 17 years at Orgalim, Europe’s Technology Industries Association, managing the organisation’s engagement related to EU energy, climate, and environment policies.
Sigrid's background includes extensive experience in environmental policy, regulatory affairs, and sustainability initiatives. She is a lawyer by training and holds an Executive Master in International Association Management from Solvay Business School in Belgium. Her professional expertise, combined with her passion for sustainability, drives her work in creating a more sustainable healthcare sector.