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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The RAPS European Council (REC) is comprised of senior regulatory professionals from across the region that support RAPS’ growing member base and volunteer network across Europe with the information and education needed not only to ensure compliance with global regulations, but also to drive regulatory excellence and advance public health.
The REC also identifies essential initiatives for strategic focus and represents RAPS and its members with EU and national authorities—providing in-depth understanding of the global and local context of regulations across the medical device, pharmaceutical and biotech markets.
RAPS is seeking qualified individuals to serve on the REC for a 2021-2023 term.
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Susana de Azevedo Wäsch is a biotechnologist and vice president of quality management and regulatory affairs with Ypsomed AG. She has more than 18 years of experience in medical devices, pharmaceuticals and biotechnology. Wäsch is experienced in the areas of regenerative medicine, implants, drug-device combination products and infusion pumps. Prior to Ypsomed, she worked at Geistlich Pharma AG, Switzerland; Eidgenössische Technische Hochschule Zürich; Lonza Visp, Switzerland; the European Bioinformatics Institute, Cambridge, England; and the Center for Advanced Research in Biotechnology in Rockville, MD, USA. After earning her MSc at the Ecole Supérieure de Biotechnologie Strasbourg, France, she performed her dissertation at the Institute of Microbiology at the Swiss Federal Institute of Technology in Zurich, followed by further training at the Executive School of Management, Technology and Law in St. Gallen, Switzerland.
Jennifer Neff is director of regulatory and medical affairs at bess AG. She has worked in medical devices, pharmaceuticals and biotechnology for more than 13 years. Prior to bess, Neff held regulatory and clinical affairs positions at Bayer, PAREXEL Consulting, NOXXON Pharma AG, Berlin Heart GmbH and Biotronik GmbH. She has worked with a broad range of devices and drugs. Prior to working in industry, Neff was as a veterinarian in small- and large-animal practice and worked for the primate genetics division of the German Primate Center. She received her PhD from the University of Veterinary Medicine of Hannover and her MBA from FOM University of Applied Sciences in Germany. Neff holds the RAC credential and is the vice chair of the RAP European Council.
Philippe Auclair is senior director, regulatory strategy and advocacy at Abbott. He represents European industry in various European Commission expert groups and actively participates as a trainer in programs organized by regulatory authorities in various geographies. Auclair has served since 2015 as an advisor to the Asian Harmonization Working Party Technical Committee. He is Chairman of the postmarket surveillance and notified body working groups of the European medical device manufacturers’ trade association, Medtech Europe. Auclair received RAPS’ Global Leadership Award in 2010, was selected RAPS Fellow in 2012 and is also the proud recipient of an FDA CDRH director’s “Special Citation” for his work with the Global Harmonization Task Force (GHTF).
Lena Cordie-Bancroft is the president and principal consultant at Qualitas Professional Service, where she works with medical device and IVD companies to implement ISO 13485 and FDA-QS-regulation-compliant quality management systems supporting processes to comply with FDA and international regulatory requirements. Cordie-Bancroft helps clients with quality systems, risk management and global regulatory compliance related to labeling and Unique Device Identification (UDI) requirements. She is a member of Association for the Advancement of Medical Instrumentation (AAMI) Sterilization Standards Committee, ISO/TC 198 and ISO/TC 210 work groups. She is an active member of RAPS, chairperson for the RAPS Twin Cities Chapter, member of the RAPS European Council and a leader of the UK Local Networking Group.
Michael Maier has more than 20 years of hands-on experience in the medical device industry working on design and development projects, product industrialization, and regulatory and quality affairs. He is a trained notified body auditor for ISO 13485 and the EU Medical Device Directive, and has served numerous international compliance programs. Maier helps clients determine the most appropriate regulatory pathways and strategies to bring devices to market, and conducts regulatory troubleshooting and compliance audits for product files, clinical investigation files and quality systems. He holds an MBA in corporate management and a masters in medical engineering. He earned the RAC Devices in 2019. Maier is a member of several standardization committees related to medical devices. He is frequent speaker at international events for medical devices, quality and regulatory affairs topics.
Irena Milobratovic is a senior regulatory affairs manager at Arriello. She has more than 15 years combined experience in pharmaceutical and medical device regulatory affairs, pharmacovigilance and market access. Milobratovic’s expertise lies within the processes which establish and keep Marketing Authorisation Holders compliant, such as medicinal products release to market, product information, labeling and regulatory compliance, as well as liaising with European and global health authorities. She has a masters of pharmacy and holds the RAC (EU) credential. Milobratovic is an active RAPS and RAPS European Council member.
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
Pallavi Trivedi has 20 years of executive career experience in regulatory affairs in world-class enterprises, multi-national organizations and entrepreneurial ventures in the pharmaceuticals industries, Pallavi is an expert in leading global regulatory strategy and product development. She is adept in strategic leadership of global registrations, compliance and life cycle management with a proven success record in handling a variety of complex biopharmaceuticals, food supplements and consumer healthcare products throughout the product life cycle. Pallavi is a result focused and detail-oriented professional with demonstrated success in building & motivating high performing teams.
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.
Andreas Wiegand is senior director of regulatory affairs at Siemens Health, where he built a dedicated group to handle US submissions for the company’s German-made products and directs the local regulatory team in charge of global submissions. After receiving a degree in Chemistry, he began his career in a lab developing IVD products and specialized in immunoassays. Weigand later worked in regulatory affairs for vaccines. He specialized in US regulatory affairs and earned the RAC (US), eventually broadening his responsibilities to cover worldwide registrations, including WHO prequalification. After working in countries including the US and the Netherlands, he returned to his native Germany, where he has been able to combine his experience with IVDs and regulatory affairs.