RAPS European Council (REC)

Robert van Boxtel is Principal Consultant and management team member at Medical Device Project B.V. in the Netherlands. For more then 10 years, he supports the medical device industry with QA and RA related consultancy, focusing on the EU and USA. Additionally, he provides training to the industry, Notified Bodies and Competent Authorities on EU MDR, ISO 13485, Risk Management, auditing etc. He is hired by the Dutch Standards Institute (Royal NEN), as SME for training on ISO 13485 and MDD/MDR. Furthermore, he participates in TC210 discussions on quality management systems, risk management, PMS and is member of the Dutch horizontal standards committee. Robert is Board Member of both the RAPS Netherlands Chapter and the RAPS European Council. Before joining Medical Device Project B.V., he worked at KEMA Quality Notified Body (now Dekra Certification) and in the medical device industry in several roles in design and production, both in the EU and the USA. As a result he has over 25 years of experience in the medical device industry.

Qualified to a master’s degree in biotechnology, based in Geneva-Lausanne area in Switzerland and working as a Vice President Regulatory Affairs EMEACLA (Europe, Middle East, Africa, Latin America, and Canada). In Nataliya’s current role she is directing and influencing regulatory strategies and guide the company through multiple regulatory changes and dynamics, including investment into capabilities and competitive edge also in the area of digital health. Nataliya also has a special focus on regulatory and clinical pathways to accelerate marketing authorization and patient access, that also includes the risk benefit approach in clinical evidence and Real World Evidence especially for therapies that address unmet medical needs. Prior to joining Edwards she was a Sr. Director Regulatory Affairs EMEA at Medtronic, headed up Regulatory Affairs at Colgate-Palmolive Europe Sarl. in Basel, Switzerland. Nataliya previously held the management positions in Research and Development, Manufacturing Process Management and Quality Assurance at Unilever company, and worked as an independent consultant to the cosmetic industry and for alternative toxicological methods.

After 12 years of basic research experience in Molecular Biology and Biotechnology across several Belgian universities, she has accumulated 22 years of pharmaceutical industry experience in Global Regulatory Affairs, leading global regulatory strategies for medicines and vaccines in various therapeutic areas. Mercè has been actively involved in regulatory policy and advocacy through proactive engagement with trade associations (e.g. IFPMA), health authorities, NGOs and supranational organizations. Her leadership roles have included serving as the World Health Organization (WHO) Regulatory liaison.

Flavia Gaudio is a regulatory leader with over 25 years of experience in both Pharmaceutical and Medical Device sectors. As Senior Director Regulatory Affairs at LivaNova, she oversees international regulatory strategies across APAC, EMEA, and LATAM. Her roles have spanned all stages of product development, from pre-market approvals to lifecycle management, covering complex product categories in the neuromodulation and cardiopulmonary space. With a strong focus on execution and innovation, she is recognized as a highly effective people leader and trusted business partner. Passionate about sustainability and digital health, she is a certified RAC (EU), an active contributor to global industry working groups, university lecturer, and a mentor in regulatory affairs.

Shakul is a seasoned Regulatory Operations/Regulatory Information Management (RIM) professional with over 16 years of experience in the pharmaceutical and contract research organization (CRO) industries.  He is currently working at BeiGene International GmBH, where he leads the Regulatory Solutions as well as the Regulatory Data management and governance function. His previous experience includes regulatory operations positions at Novartis, Baxter, Baxalta, Shire, Takeda, PRA and IQVIA.  Shakul's expertise includes leading and driving global strategies for GRA systems, global submission publishing and delivery, submission standards, document management, and regulatory information management (including XEVMPD and IDMP) as well as the potential future state of regulatory digitalization, such as artificial intelligence, automation, etc.

Ella Helgeman is Senior Director, Global Regulatory Affairs in Radiometer, Danaher Group. Ella holds MSc EE and MBA and she is an accomplished regulatory professional with over 20 years of experience in the medical device and in vitro diagnostics industries, where she help organizations navigate complex regulatory environments while ensuring the highest standards of quality. Over the course of her career, she has held leadership roles at Medical device and IVD manufacturers and Notified body, heading Regulatory and Quality departments at Intertek Medical Notified Body AB (IMNB AB) , Vice-Chair of the NBCG-Med Technical Group, as a participant and chair of multiple Team NB working groups. As a trusted expert in the field, Ella represents Denmark and Sweden as a TEAM-PRRC country representative and serves actively MedTech Europe in MD Regulatory Affairs Committee and IVD Regulatory Affairs Committee. Dedicated to sharing knowledge, she has spoken at more than 20 MedTech conferences globally, providing insights and fostering dialogue within the global regulatory community. Ella is acting as Co-Chair and Country Lead for Sweden in RAPS Nordic Local Networking Group and is proud contributor to the Regulatory Affairs Professionals Society.

Sven Hoffmann has an educational background in biotechnology engineering with more than 18 years’ work experience in the IVD sector. He is the Head of IVD and Principal Consultant at Entourage GmbH, an international consulting company in the Medical Device and Pharmaceutical area. Before joining Entourage GmbH, Sven has worked for TÜV Rheinland for more than 15 years, a leading German Notified Body and Certification Body in the Medical Device / IVD sector. During his time at TÜV Rheinland he has held both, technical roles (e.g. Certification Officer, Lead Auditor and Technical Expert/Reviewer) as well as management positions (Global Head Business Segment IVD, Global Head Technical Competence Center IVD and department Head IVD Germany). For his last 4 years with TÜV Rheinland , he was globally responsible for the entire IVD business segment, including certification services under IVDR, IVDD, EN ISO 13485 and MDSAP. In this role he also represented TÜV Rheinland in all relevant stakeholder meetings and working committees for IVD related topics (e.g. TeamNB, meetings with MDCG, meetings with MedTech Europe or VDGH). Previous to his TÜV Rheinland career, Sven worked in the manufacturing area of Abbott Diagnostics (Delkenheim, Germany) for 3 years, gaining industry experience in the production of immunoassays for infectious diseases diagnostics. Sven has profound knowledge in regulatory affairs and QMS requirements, technical experience with a broad range of immunoassays and NAT based IVDs, paired with multiple years of experience with operational and team management.

Colette Shortt is a Regulatory Director, Emerging Science & Innovation, Global Franchise Organization. Before joining J&J, Colette was Science Director at Yakult and held a Research Nutrition position at SmithKline Beecham Consumer Healthcare. Colette has been active in the development of product-related standards and health claim substantiation throughout her career (Joint Health Claim Initiative, Council of Europe, PASSCLAIM) and coordinated one of the first successful disease risk reduction health claim regulatory submissions in Europe while at McNeil Nutritionals Ltd. Colette is a Visiting Professor to Ulster University, Registered Nutritionist and Fellow of the Association for Nutrition and the Royal Society of Medicine. She is active on the Boards of the International Life Science Institute, and the Pharmabiotic Research Institute. She is a graduate of the National University of Ireland, Cork with post-graduate qualifications in nutrition (MSc, PhD) and a business qualification (MBA) from the School of Business Management, University of Surrey. As part of her post-graduate education, she was research active in Ireland, Canada and at the Rowett Research Institute, Scotland. She was one of the founding editorial board members of Trends in Food Science & Technology.

Thierry is Team Lead Innovation and Operational Excellence for Productlife Group company. With a background in chemical engineering, Thierry spent seven years in the medical device industry developing an innovative medical device. During this time, he transitioned to quality and regulatory roles. In 2005, he joined the French competent authority in the medical devices and in vitro diagnostic devices department. Holding various management positions, covering all the activities of a competent authority, from qualification and classification to the authorization of clinical investigations, including vigilance and market surveillance. Thierry oversaw the implementation of processes to support innovation. Between 2012 and 2025, served as deputy director and then director of medical devices and in-vitro diagnostic devices. In this position, he participated in numerous European groups. In the field of software, he was involved in the European group attached to the Commission, as well as in the IMDRF working group. Finally, worked on the deployment of the current regulatory framework as the French representative to the Medical Device Coordination Group (MDCG) and as a member of the Competent Authority for Medical Device (CAMD) bureau, where Thierry held the positions of vice-chair and chair in 2024.

Kate Stockman is a regulatory leader with 19+ years experience within both the Consumer and Pharmaceutical sectors. Kate has led local, regional and global regulatory teams. Her roles have spanned all stages of product development (pre- and post-licensing) and across variety of healthcare product categories ie Rx & OTC medicines, medical devices, dietary supplements & cosmetics. Kate has a strong focus on delivery with a track record of developing innovative regulatory strategies that have delivered multiple new, competitive product approvals across a broad range of complex geographies. Kate is a highly effective people leader and valued business partner.

Email:

[email protected]

Phone:

+44 7703 389978