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.Show more
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.Show more
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.Show more
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.
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
John joined NSAI in 2022 as Industry Engagement Officer in the Medical Devices Department to support NSAI’s offering as a Notified Body through stakeholder and client engagement. In his early career he worked as an engineer in, amongst other industries, medical devices and pharmaceutical tooling in Ireland, China & Malaysia. He transitioned his skills towards a consultative sales career with Smith & Nephew, Olympus and most recently Abbott. He is a graduate of DCU, Ireland with a BEng in Mechatronics and UCD Michael Smurfit Business School, Ireland with a MSc in Management.Show more
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 companyShow more
Laura is a Regulatory Affairs Program Manager at Medtronic based out of Galway site, with primary focus on post market activities. She has over 20 years’ experience in the medical device industry, working in regulatory affairs for the last 15 years. Most recent role involved being the RA Core Team member for the Coronary and Renal Denervation Operating Unit’s EU MDR Program, with particular emphasis on transitioning of the Class III cardiovascular devices and combination devices to EU MDR. She holds a BSc degree in Industrial Biochemistry from the University of LimerickShow more
Killian Haycock is the Quality Assurance Manager in BlueBridge Technologies. BlueBridge Technologies designs, develops, and delivers regulated digital health solutions for pharma and medical device companies around the world. BlueBridge is certified to ISO 13485:2016, IEC 62304:2006+A1:2015, and ISO 14971:2019, and has extensive experience in delivering full lifecycle digital health solutions, from concept, to regulatory approval, and through the post-market activities. BlueBridge specialises in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and Medical Device Software (MDSW).
Killian leads the team of Quality and Regulatory specialists in BlueBridge, with focuses both on the design controls of medical devices, and on the maintenance of the quality management system. He and his team bridge the gaps between the complex verticals in this industry, including systems engineering, design, development, risk management, cybersecurity, human factors, verification, validation, compliance, and regulatory affairs.
Leader of Medical Device Software Development, Quality and Regulatory Affairs and currently Director of Regulatory Affairs and Quality Assurance, with Atlantic Therapeutics who are developing Medical Device Software for their INNOVO® brand.
Ex-Notified Body (NSAI) as Software Technical Reviewer, Senior Certification Officer and QMS Auditor and member of MDCG for New Technologies developing guidance for industry. Convenor & contributing member of ISO Risk Management Standards.
Trainer for Meddev Solutions, part of Trinzo Group providing SaMD and Cybersecurity training to medical device professionals (IEC 62304 and IEC 81001-5-1).
25+ years’ experience with Life Sciences, with leading organizations such as Boston Scientific, Bioniche (Mylan), EDS, J&J, Novartis, Olympus.
PhD candidate with The Regulatory Software Research Centre (RSRC) under DkIT-DCU, developing EU Regulatory Requirements for Software Medical Devices within the scope of AI/ML.
Seán has been with the NSAI since 2019 where he initially started as a Certification and Inspection Officer performing site audits under EN ISO 13485:2016 and reviews of technical files. Seán has been a reviewer of MDD, IVDD and MDR technical files.
He was project lead for NSAI’s IVDR Designation and is site auditor and product reviewer under the IVDR. Recently he was appointed as European Medical Devices Operations Manager and as interim Head of the Notified body.
Seán is passionate about the effective implementation of the new Regulations 2017/745 and 746 and believes that a pragmatic approach can be taken by all stakeholders to ensure compliant devices reach the patients that depend on them.
Erik O Donovan, Head of Digital Economy Policy, with the business group, Ibec (2016 to date).
Leads and provides cross-sectoral policy and representation services to Ibec networks in engaging national, EU and OECD partners on digital and AI policy affairs.
He represents Ibec on the Government’s Enterprise Digital Advisory Forum, established to support the government in driving the digitalisation of enterprise across Ireland.
With Ibec since 1999, he has held a range of senior roles including: the Brussels-based Head of Ibec Europe, Ibec’s permanent representation to EU institutions and stakeholders; energy; and the green transition. Previously worked in pharmaceutical industry.
Interested in lifelong learning with third level qualifications in: analytical science, environmental science, economic policy, European law, cyberpsychology, design thinking and digital policy.
Ida Foley is the Director of Regulatory Affairs, EMEA at Teleflex. She joined Teleflex in June 2011 as a Quality Systems Specialist and has built her knowledge and career over the past 12 years, holding multiple positions within the QARA function. She was Senior Manager of Quality System prior to moving into her role as Director of Regulatory Affairs.
Prior to joining Teleflex, Ida worked at Boston Scientific Tullamore where she started in the MedTech Industry holding various roles in Quality from 1998 to 2009.
Ida holds a BSc. in Quality Engineering and has also completed the MSc. in Medical Technology Regulatory Affairs through the Atlantic Technological University Sligo and University of Galway. She is a member of various Irish Medtech Association (IMA) Task Forces supporting the IMA QARA Forum and is a member of the IMA Regulatory Steering Committee.
He has 30 years experience in the medical device industry and currently works at surgical device company Palliare which he co-founded in 2018. He previously worked at Medtronic following their acquisition in 2017 of GI Diagnostic company Crospon which he founded in 2006. In 1998 he co-founded Caradyne, an Irish respiratory medical device company, which was acquired by Respironics Inc. in 2004. In the past 35 years he has held R&D management positions in Nellcor Puritan Bennett and engineering positions in Digital Equipment Inc. and in Dataproducts Inc. He is a past Chairman of the Board of the Irish Medical Devices Association, and a Past President of Engineers Ireland.Show more