The Emergo Team in Europe and the Middle East
Emergo Group maintains its offices in North and South America , the Asia Pacific region, Europe and the Middle East. Below is a selected list of consultants and employees based in Europe and the Middle East. Click on one of the following links to meet our team located in: FRANCE | ISRAEL | NETHERLANDS | RUSSIA | UNITED KINGDOM
FRANCE
HOUOT, David - Senior Consultant (Lyon)
Prior to joining Emergo Group, David worked with French Notified Body LNE/G-MED as a medical devices certification project manager within the implantable and invasive medical devices unit. He has extensive experience in technical file assessment and was a lead auditor for CE marking worldwide. David has expert knowledge in ISO 9001, ISO 13485, the European Medical Devices Directive and many other European harmonized standards, as well as global regulatory knowledge on medical device regulations for USA, Canada, Australia, New Zealand, Taiwan and Japan. David is a member of S95R committee (Sterilization, Disinfection and Sterilizers) at AFNOR (French Agency for Standardization). Education: Diploma of Specialized Studies (one-year postgraduate degree) in Safety of the Industrial and Medical Systems (quality, security, reliability), Nancy, France; Masters of Science and Technology (four-year university degree) in Biological and Medical Engineering, Nancy, France; Two-year university degree in Electric Engineering and Industrial Data Processing, Nancy, France.
MARTIN, Franck - Country Manager & Senior Consultant (Paris)
Franck joined the Emergo team in 2009, spearheading the opening of Emergo Group's new office in Paris and adding further depth to our team in Europe. Franck brings to Emergo Group a comprehensive understanding of international quality system, regulatory and product compliance issues, gained during six years spent working with French Notified Body LNE/G-MED. In addition, Franck has worked for respected device manufacturers including Alcon Labs and Bernas Medical, experience that gives him a uniquely holistic perspective on regulatory compliance. Education: Three year university degree in Physics and Optics, Lasers and Optic Fibers, Université Paris XI & Institut d'Optique Graduate School, Paris, France; Two year university degree in Physics and Mathematics, DEUG A, Université Paris XI, Paris, France.
ISRAEL
AVADIS, Danielle - Medical Director (Haifa)
NETHERLANDS
BRASTER, Patrick - Distribution Consultant, Europe (The Hague)
Patrick Braster has extensive experience working for a leading distribution development company in Europe. This, coupled with his background in marketing management and client relations, gives him a well rounded, real-life understanding of what it takes to properly evaluate, manage and monitor distributors in Europe. Prior to joining Emergo, Patrick served as International Business Development Manager for EuroDev BV based in The Netherlands. In this role, Patrick was responsible for setting up and running the European distributor network of several US consumer and industrial goods manufacturers. Patrick also brings a wealth of knowledge about the medical devices arena to the Emergo team. Education: B.A. in International Marketing Management, University of Professional Studies (HES), Amsterdam, the Netherlands.
HART, Regina - Senior Clinical Consultant (Amsterdam)
With over 18 years working in the medical device industry, Regina has gained significant experience monitoring clinical studies for medical devices, including heart valves, catheters, wound dressings and orthopedic products. She has also assisted with patient recruitment, collection of regulatory data for submissions and developing a network of sites and investigators. Regina's significant language skills - Dutch, German, English, French, Italian and Spanish - have also proved extremely important for managing cross border clinical studies. Education: University of Amsterdam, German and Italian language and literature; University of Amsterdam, Dentistry (foundation course); European School, International Baccarauleat Bergen, The Netherlands.
KASTEEL, Edgar - Partner, Emergo Distribution Management Services (The Hague)
Edgar is an international business development expert with many years of experience in advising American and Asian businesses in establishing or expanding business in Europe. Prior to joining Emergo, Edgar served as the Vice President of the Holland International Distribution Council, during which he traveled frequently to speak at seminars and meet with companies to discuss opportunities in Europe. Edgar also spent several years working as a Senior Consultant at a reputable management consulting firm in the Netherlands, where he developed and implemented business concepts and strategies in the field of distribution. During his military service as Second Lieutenant with the Royal Netherlands Air Force, Edgar conducted performance audits on several operational units and HR and administrative departments and was involved in several projects in the field of quality control. Edgar speaks English, Dutch and German. Education: B.A. in Business Administration , The Hogeschool Eindhoven, The Netherlands; Additional courses on Financial Management, Consulting skills, Physical Distribution Management, Strategic Information Planning and Project Management.
KOLBER, Neal - Project Manager, Europe (The Hague)
If you are an Emergo client, chances are likely that you will speak to Neal at some time. As Emergo Group's Project Manager, Neal is responsible for assigning, coordinating and scheduling all client projects for Emergo's consulting team. Neal's experience in project management was honed during several years spent working for the French Ministry of Education in Lyon and his roles in Business Development and Account Management with a Texas-based network security firm and defense contractor. He also has complete command of Emergo's electronic project management system used to plan and maintain hundreds of projects each year. Neal is fluent in French, and clients enjoy working with him because of his attention to detail, excellent follow through and easy-going demeanor. Education: B.A. in Arts, Minor in International Business, University of Texas.
LAUFER M.D. PharmD, Jaap - Vice President, Public & Government Affairs (The Hague)
Jaap has 25+ years of experience in Regulatory and Medical Affairs at major pharmaceutical and technology-intensive medical device companies. He serves as Senior Regulatory Counsel to the Management or Board of several major medical device manufacturers, but also of venture capital funded companies. In addition to working with Emergo Group, Jaap manages his own regulatory consulting firm serving medical device and IVD clients worldwide. He was also VP of Regulatory and Clinical Affairs for LipoMatrix, Inc. in Neuchatel, Switzerland. Before he joined LipoMatrix, Jaap held a number of managerial positions of increasing responsibility within Pfizer. In this capacity he was responsible for regulatory approval and compliance concerning a variety of active and non-active medical devices. On top of being an experienced auditor for compliance with ISO (accredited with ZLG) and FDA Quality System Regulations, Jaap managed many clinical studies, sometimes from inception to publication. He is a regular contributor and past Chairman of Regulatory Affairs Professional Society (RAPS), Europe (1993-1996) and a visiting teacher to the School of Pharmacy at the University of Southern California (USC). Education: PhD in Medicine, University of Nijmegen, The Netherlands; PhD in Pharmacy, University of Groningen, The Netherlands.
RUSSIA
MAKAROVA PharmD, Elena - Senior Consultant, Russian Regulatory Affairs (Moscow)
Based in Moscow, Dr. Makarova is Emergo Group's expert on medical device regulatory compliance issues for the Russian Federation and neighboring CIS countries. Her past experience working in the Moscow offices of respected medical device and pharma companies such as Baxter, IPSEN and Merck have given her an in-depth understanding of the compliance challenges that face life sciences companies operating on a global scale. Dr. Makarova assists Emergo clients with regulatory dossier preparation, clinical trial applications, and regulatory strategy in Russia and CIS countries, and acts as the liaison between Emergo clients and the Russian Ministry of Health. She is fluent in English and Russian. Education: The Russian Academy of Foreign Trade; MBA in Marketing; I M Sechenov Moscow Medical Academy; Doctor of Pharmacy, specialized in Pharmacy and Chemistry.
UNITED KINGDOM
ARNOLD-ROUND, Jane – Senior Regulatory Consultant (London)
Jane has 18 years experience in the pharmaceutical and medical device industries and is an expert in the fields of cardiovascular, tissue sealant and animal tissue-engineered devices. She has significant experience with development of CE Marking strategies, design dossier preparation and review, ISO 9001:200, ISO 13485 and biocompatibility and sterilization issues. Prior to joining Emergo, Jane was with Medtronic and the UK Notified Body BSI, where she served as the primary Scheme Manager for clients in the wound care sector, including manufacturers of antimicrobial dressings, haemostatic products and a broad range of chronic care and first aid products. Jane handled classification, borderline issues and numerous drug-device combination design dossier reviews. Education: BEng in Mechanical Engineering, Leeds University; MSc in Bioengineering, University of Strathclyde.
HARWOOD, Joanne - Quality Consultant (Leeds)
Joanne has seven years experience in industry, the last three of which were spent as QA Manager for a UK manufacturer of implantable cardiovascular devices. She offers her expertise and experience in the implementation and maintenance of ISO 9001:2000 and ISO 13485:2003 (including analysis of compliant data and CAPA data, conduct of internal audits and representation at Notified Body audits) and in the creation and maintenance of CE Marking technical documentation for medical devices. Qualifications: City & Guilds: 7430 Part 1 and 2 Certificate in Quality Assurance.
LOVE, Richard - Senior Quality Consultant (Glasgow)
MISTRY, Tina - Regulatory & Clinical Consultant (Manchester)
Tina is an experienced clinical trial monitor with extensive knowledge in EU and US medical device regulations. Formerly with the MHRA, Tina was responsible for the technical handling of clinical investigation notifications and the regulation of medical devices. She maintained a register of UK manufacturers of low risk and in vitro diagnostic devices and assisted in the operations of the vigilance system for adverse incidents occurring within clinical trials reported by manufacturers. Tina also handled code of practice queries on the medical device regulations. Since then, Tina has worked on a range of regulatory and clinical projects and continues to gain experience in medical device consulting. Education: BEng in Medical Engineering, University of Bradford; MSc in Biomedical Engineering, University of Manchester.
MCGURTY, Doug - Senior Clinical Consultant & Biostatistician (London)
Doug recently joined the Emergo UK team, providing clinical and statistical services to Emergo's expanding client base. He is an experienced research professional with significant technical and managerial skills and international experience, gained during the past 15 years, with a renowned academic institution, major US & European research sites and orthopedic medical device corporations. Prior to joining Emergo, Doug was responsible for the management of post market surveillance studies of orthopedic devices for International Clinical Affairs. He introduced clinical audit and research programs for several global companies and developed and implemented updated SOPs to ensure compliance with "Best Practice" benchmarking for the conduct of clinical studies linked to the ICH GCP standards (CPMP/ICH/135/95). Doug also worked previously as the Clinical Research Audit Director at the University of Dundee, where he managed a clinical research support staff and co-authored 14 published research papers in peer-reviewed journals. Education: BSc in Applicable Mathematics, Dundee Institute of Technology; HNC in Electrical and Electronic Engineering, Kingsway Technical College, in conjunction with apprenticeship as a Design Draughtsman with Bonar Long Ltd.
OSBORNE, Karen - Management Accountant, Office Administrator & Clinical Trials Administrator (Sheffield)
If you call the Emergo UK office, Karen is likely the first person you will speak with. Karen keeps the office running smoothly by taking on a variety of responsibilities, including handling incoming client inquiries, preparing management accounts and providing general support for the Emergo UK team. Karen is also responsible for bookkeeping and payroll, with her strong background in accounting, including four years spent in an accountancy practice. Education: BSc (Hons) in Accountancy 2:1, University of East Anglia, Norwic.
RAMSAY, Sarah - Regulatory Consultant (Manchester)
Sarah brings to Emergo more than six years of regulatory affairs experience. She has significant experience with technical files, design dossiers, vigilance procedures and reporting and US FDA 510(k) applications for orthopaedic implants (including devices intended for implantation in the spine). In her previous work with UK bone cement manufacturer, DePuy CMW, she was responsible for preparation of regulatory applications and compliance with regulatory requirements for European, Canadian, Australian and US markets. Education: BSc (Hons) in Biological Sciences, Lancaster University.
RYLETT, Colin - Managing Director, Europe (Sheffield)
Colin has held a variety of business development and financial management roles throughout his professional career. He started at PricewaterhouseCoopers where he trained as a chartered accountant, prior to moving into industry to work for a large energy group. During his role as a finance director for a medical devices group, Colin gained significant experience with technology assessment, project management and the medical devices sector. In 2002, Colin started his own advisory consultancy for medical technology businesses. Colin now provides strategic direction and oversight for Emergo's European operations. Education: BA (hons) & ACA in Accounting & Financial Management, Sheffield University.
SOMERVILLE, Grahame - Senior Regulatory & Quality Consultant (Edinburgh)
Grahame has significant experience with regulatory approvals in Europe, United States and Asia. He is an expert in absorbable and non-absorbable surgical sutures and ophthalmic products, in particular contact lenses and solutions, gained from 25 years of medical device experience with Jonson & Johnson and Bausch & Lomb. Grahame is also a "Qualified Person" for pharmaceutical products and has worked on a number of projects with manufacturers of wound care and orthopedic products. He is an elected member of the Professionals in Regulatory Affairs (TOPRA) and a chartered chemist of the Chartered Quality Institute (MCQI). Education & Qualifications: BSc (Hons) in Chemistry, Paisley University; DMS, CSci, CChem, MRSC, MCQI, MTOPRA DIPS.
WEBB, Kevin - Head of Regulatory & Quality Assurance, Emergo UK (York)
As Head of Regulatory and Quality Assurance for Emergo UK, Kevin manages and provides regulatory consultancy services to manufacturers of medical devices and human tissue-derived therapeutic products. This includes the generation and review of regulatory approval strategies, enabling timely and cost-effective international market entrance of clients' products. He also assists manufacturers with applications for international regulatory approvals (including compilation and submission of product dossiers, answering queries in relation to the application and liaison with international regulatory authorities). Kevin has over 18 years experience in pharmaceutical and medical device industries. Education: BSc (Hons) in Applied Biology (Biochemistry), Hatfield Polytechnic.
WILLINS, Marjory - Senior Clinical Consultant (Edinburgh)
Marjory has extensive research experience, specializing over 20 years in medical devices with Johnson & Johnson. Most recently, Marjory focused on clinical research management and operations, supporting and delivering high quality clinical trials (including regulatory and post marketing). She has been involved in all aspects of clinical research from set up, project management and monitoring to final report and publications for a range of products in differing therapeutic areas. Marjory also possess a strong quality compliance background and CRO and consultancy experience. Education: BSc in Biology, Aberdeen University.
YOUNG, Richard - Senior Regulatory Consultant (Bristol)
Richard brings to Emergo a wealth of global regulatory knowledge, having held over 15 years of experience in various regulatory, quality and clinical roles for major companies, including Bard, ALARIS and Zimmer. He is an expert in orthopedics and electro-medical devices and has significant experience with GMP, GLP and GCP. Richard is a member of the Eucomed Standards Focus and Regulatory Focus Groups. Education: BSc in Botany, MSc (Hons) in Microbiology, University of Canterbury, New Zealand.
