The Team

Meet the dynamic team creating compliance for safer European markets

The Obelis team is led by a Board of Directors that brings decades of professional expertise in Regulatory Affairs and Quality Assurance within the European Union.

To help us work towards the mission “To be the consultant of choice by shaping the compliance industry and providing the most effective compliance process”, we’re supported by an Advisory Board.

This is comprised of several accomplished experts with extensive experience in Regulatory Affairs, medical technology, lobbying, business management, marketing and organizational development.

Last but not least, we have our team of  managers & expert consultants facilitating compliance and entry onto the European market for manufacturers in multiple sectors from medical devices and cosmetics to consumer goods…


ADVISORY BOARD

Jean-Marie Vlassembrouck

Jean-Marie Vlassembrouck has over 30 years of experience in healthcare first in the pharmaceutical industry, then in the medical devices, biological and biotech industry.

He established and held the European regulatory and industry affairs position for 3 M healthcare in Europe for 8 years. He then joined Baxter for 20 years, being responsible successively for Industry and Governmental Affairs in Europe, Public Affairs in Europe and finally appointed as Vice-President of Industry affairs worldwide for the Bioscience division.

He was involved with Eucomed, now Medtech Europe for a long time, being the Chairman of the association for 5 years. He also acted as Chairman of the Global Management Committee of the Plasma Protein Therapeutic Association for 11 years. Jean-Marie is still active today through his consultancy company providing strategic support on market access issues.

Ariela Bardach

Ariela Bardach has 30 years of experience in the organizational development field. She started her career as an organizational consultant in one of the leading consultancy firms in Israel, serving various organizations, governmental ministries, municipalities and the Israeli army. She later led the HR department of a holding company in the high-tech industry.

For the last 10 years, she has designed, through her consultancy company, growth platforms for employees and organizations, laying the infrastructure for both individual self-fulfillment and organizational aggregated development. She also does executive mentoring and develops leadership programs.

She is a strong advocate for non- linear, agile thinking, for the strong bond between individual progress and collective organizational progress. Her passion is empowering people to develop their potentials to the fullest, to bring value to their working place and to their personal life. Her professional interests focus on finding the next advantage, paradigm shifting and behavior change. She also serves as a member of the Obelis Advisory Board. She received her M.Sc. in management science from Tel Aviv University.

Dario Pirovano

Dario Pirovano has over 30 years of experience in Medical Technology, as designer and regulatory affairs expert. He worked for 7 years as R&D and regulatory manager with Ohmeda in Milan signing some 20 projects for anesthesia machines, lung ventilators and neonatal care devices.

He worked for 4 years within the Commission of European Communities where he contributed to drafting and negotiating the 90/385 /EEC and 93/42/EEC directives. He was then director of Medical Technology Consultants Europe from 1991 to 1995. In 1995 he founded Pirovano Management SPRL, a consulting firm advising manufacturers, Notified Bodies and authorities in regulatory matters related to Medical Technology. Dario can be considered the historical memory of the development of medical devices regulation in Europe.

Dario holds a Doctorate in Engineering from the Politecnico di Milano. Italian being his mother tongue, Dario is also fluent in English and French with basic knowledge of German and Spanish. Since 2002 Dario is Senior Regulatory Affairs Adviser for Eucomed on a consulting basis.

John L. Webster

Mr. Webster has over 40 years of quality assurance, regulatory and management experience and served for many years as European Director of Regulatory Affairs for Boston Scientific based in Paris and previously for Meadox Medicals Inc. in UK.

Most recently, he was Principal Consultant and Managing Director of the European office of US based organisation providing medical device consulting and European Authorised Representative services. Since 2010, Mr. Webster has served as Senior Regulatory Consultant for the Obelis Group based in Brussels and providing EU Consultancy Services and Authorised Representative Services for the Medical Device and other Directives.

During the writing of the Medical Device Directive, he was responsible for technical affairs at EUCOMED representing the medical technology industry in Europe, and chaired the committee writing the Essential Requirements in Annex I of the Directive. Mr. Webster has chaired the committee responsible for writing the European standards on labelling and symbols used with medical devices (CEN/CLC/TC 3/WG 1) since its creation.

He regularly speaks at professional conferences on all aspects of medical device quality and regulatory compliance. He holds a higher degree in Chemistry from the University of Newcastle upon Tyne, is a Chartered Chemist and a member of the Royal Society of Chemistry (C.Chem, M.R.S.C.), holds a Diploma in Management Studies from the University of East Anglia, is Certified as a Quality Engineer by the American Society of Quality, is a Fellow of the Regulatory Affairs Professional Society (RAPS), serves on the European Operating Committee and is Regulatory Affairs Certified (RAC).

Dr. Janette Benaddi

Janette Benaddi is a business mentor, international speaker, author and consultant to the life science industry.  Janette has over 20 years’ experience in the field of medical devices including regulatory and clinical affairs.  In 1998 she setup and grew a very successful medical device consultancy, which she later sold in 2013.

Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles during her career in the industry.

She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.

Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, she holds a teaching certificate

and is a Chartered Scientist and Chartered Director. She also has an honorary doctorate in health sciences.  Janette is a seasoned non-executive Director and sits on the board of several medical device and other industry companies.


BOARD OF DIRECTORS

CEO – Gideon Elkayam

Gideon Elkayam is the founder, owner and CEO of the “Obelis Group” since 1988.

The company has been providing the most effective EU Regulation services to thousands of companies worldwide for the past 30 years. Mr. Elkayam is the founder and current Chairman of the European Cosmetics Responsible Person Association (ERPA), founding member and Treasurer of the European Association of Authorized Representatives (E.A.A.R) and the General Manager of GiDoS sprl.

He has put all his efforts and valuable professional experience into creating Obelis, known today as the largest regulatory center in Europe, operating worldwide and covering a large scale of products with unique expertise in Medical Devices, Cosmetics, In-Vitro Diagnostics as well as non-medical equipment. He is a professional manager who inspires his team to accomplish their best performance every day.

COO – Doram Elkayam

Doram Elkayam’s career encompasses more than 20 years of professional experience focusing on leadership and higher management.

As Chief Operations Officer (C.O.O.) at Obelis for over a decade, he has gained in-depth legal and regulatory expertise in EU affairs with a special focus on medical devices and cosmetic products.

Being a strong advocate of education, lecturing at different events and providing educational seminars belong to his daily activities. As part of Obelis’ vision of creating compliance for safer markets, his passion is providing tailored solutions to the needs of brand owners who wish to penetrate the European Market.

CCO – Sandra Ferretti

Sandra Ferretti is a Chief Compliance Officer with over 20 years of professional experience.

At Obelis s.a. she gained unique expertise in European regulatory affairs in the fields of cosmetics and medical devices. She specializes in the profession of Responsible Person and Authorised Representative.

As a Public Affairs Director, she is very involved in ERPA and EAAR associations, and she advocates in various EU experts working groups: Standing committee on Cosmetics, CPNP, Claims, Cosmetovigilance, EUDAMED, and many others.

Having a broad and transversal expertise in public affairs, regulatory affairs, Cosmetics & Medical Devices Regulation, quality management system including internal auditing, as well as H2020 projects, she is regularly invited as a speaker at various international seminars and conventions.


EXPERT CONSULTANTS

Manager – Roland Gerard

Scientific Department Manager & Management Representative (QMS)

Roland Gerard is a regulatory affairs expert with 30 years of experience in the field of high risk implantable medical devices.

Roland has worked for the European Committee for Standardization (CEN), Intermedics and more recently for St. Jude Medical where he occupied the position of Vice President RA/QA in the International Division.

During all those years, he has developed an in-depth knowledge of EU Medical Device Directives and Environment Legislation as well as standards and quality management system (ISO 13485) implementation and certification, has extensive experience in CE marking and in dealing with competent Authorities and Notified Bodies, has experience in working with senior management to support business needs, speed up market access and manage crises.

Mr. Gerard has been a member of GHTF study group 2, GHTF Steering Committee, President of RAPS Europe, President of IAPM, Chair of the Regulatory Affairs Committee of IAPM and more recently Chair of the Regulatory Affairs Committee of EUCOMED. He has been involved in numerous conferences as a speaker as well as in the development of the new Medical Devices Regulation.

Senior Consultant – José Amsing

Sales & Marketing Department

José Amsing joined Obelis with a wealth of experience in International Business Development. As a Senior Consultant, she is responsible for advising companies on regulatory aspects when selling on the European market, allowing them to access new market opportunities in Europe.

Her career has started with a tenure of 10 years at Citigroup where she was responsible for business development within the corporate bank in a variety of role s and locations. Before moving to Belgium, she has lived and worked in New York for several years, in the last capacity as Director of NFIA New York where she was responsible for maintaining relationships with American companies established in the Netherlands and generating new business opportunities.Ms. Amsing has built expertise in both the private and public sector. Having worked and lived in different countries, she has developed an all-round viewpoint.

Senior Consultant (USA Branch) – Stacy Livingston

USA Branch

Mrs. Stacy Livingston (formerly Stacy Edelen) played a pivotal role in the creation and establishment of Obelis’ operations in the USA, including the opening of its USA branch in December 2009. Stacy currently serves as Senior Consultant, with over a decade of expertise in EU Regulatory Affairs.

Throughout her career with Obelis, Stacy has fulfilled different roles in Obelis – marketing, business development, sales, regulatory liaison, client administrator, speaker and event manager. All of these roles have made her a vital player in the promotion of Obelis’ services and the understanding of EU regulatory requirements across many industries in the United States. Stacy is from Denver, Colorado and graduated from the University of Utah with a double Bachelor of Science, in Marketing and Psychology.

Obelis US office is located in Montgomery, Texas.

Senior Consultant – Luminita Pascanu

Scientific Department & Executive Personal Officer to the CEO

Luminita Pascanu received a MSc in Applied Social Psychology from the Vrije Universiteit in the Netherlands and a BA in International Communication and Management from the International University in Germany, and completed studies in the US and Singapore.

With her communication and management background and her practical experience in the regulatory field accumulated in the last 8 years, Luminita holds a Regulatory Affairs and Quality Assurance Senior Consultant position at Obelis.

Luminita is an advocate of practical and customized solutions with a focus on meeting regulatory requirements as well as the clients’ business needs. With a detail-oriented approach, she provides clients with a thorough understanding of the European regulatory framework with the goal of facilitating their products’ compliance processes towards their entrance to the EU market.
Within her current role at Obelis, Luminita is also responsible for quality compliance with ISO 9001 and ISO 13485, regulatory research, vigilance and cosmetovigilance processes.

Senior Consultant – Marika Zielinska

Sales Department

Mrs. Marika ZIELINSKA serves as Senior Consultant at Obelis, with almost a decade of expertise in EU Regulatory Affairs. Marika played a pivotal role in the creation and establishment of Obelis’ NEW Sales Department as it stands today.

Throughout her career with Obelis, Marika has fulfilled different roles in Obelis – marketing, business development, sales, speaker and event manager. All of these activities have made her a vital player in the promotion of Obelis’ services and the understanding of EU regulatory requirements across many industries worldwide. As a confident and knowledgeable speaker, speaking at dozens of international trade shows and events, Marika serves as the Training Officer within Obelis Sales Department, responsible to create and deliver regulatory trainings, online or on-site.

Expert Consultant – Mathias Acciai

Customer Relations Department

Mathias Acciai obtained a master’s degree in Linguistics from the University of Bologna. As of 2012, he has become accustomed to enhancing customers’ expectations worldwide.

He is experienced in different fields, from Heavy Equipment Machines, to Intellectual Property and now Regulatory Affairs. As a Clients Relations Expert Consultant, Mathias is a firm liaison between the Obelis Regulatory Team and our clients. Beside English, he is ready to give heed to you in French and Italian to deliver an extraordinary Obelis experience.

Expert Consultant – Mark Adjei

Accounting Department

Mark Adjei received a Graduate degree in Accountancy and Taxation from CVO Lethas and is currently working  as senior consultant at Obelis S.A. in the Accounting Department.

A strong advocate of hands-on, flexible, sociable and with team spirit and open for enhancing his economical skills.  He involves his students in Accounting tasks, Statistical reporting and varieties of communication services which leads to problem solving. His professional interests focus on Financial reporting and reconciliation, application of the accounting laws and principles, reconciliation of bank statements, as well as payroll activities and  his current projects include VAT declaration.  In addition, he serves as an Expert Consultant for Obelis SA and  reports direct to the CEO.

Expert Consultant – Valya Krusheva

Administration Department

Valya Krusheva received a MSc in International Business Economics and Management from KU Leuven and completed dual BA in European Studies and Political Science and International Relations from the American University in Bulgaria.

She has gained international experience in business operations by working in the USA, Bulgaria and Belgium.

Expert Consultant – Patricia Morales

Human Resources Department

Patricia Morales graduated from Business Administration with a master’s degree in Human Resources Management by the Universidad Autónoma de Madrid. Her education background is complemented by a certification in Gender Equality at Work Environment and a degree in Psychology.

Her professional background is composed of 5 years of international HR experience within demanding and high standards environments in 4 different countries. This experience allowed her to gain extensive knowledge of the best HR practices and efficient & healthy multicultural workplaces.

Patricia is passionate about Diversity, Women Leadership, Innovation and People Development, supporting them as the main tools to achieve competitive advantage. For her, there is no organization growth without the growth of its people.

Expert Consultant (Israel Branch) – Hemi Zimmerman

Israel Branch

Mr. Hemi Zimmerman’s career encompasses more than 40 years of professional experience focusing on marketing and management. As Expert Consultant at Obelis for over a decade, he has gained in-depth knowledge of the Israeli Market, with extensive professional connections with the medical devices and cosmetic industries in Israel.

As part of Obelis’ mission “To be the consultant of choice, by shaping the compliance industry and providing the most effective compliance process” – customer relations has been his most vivid contribution to the operations of the Israeli Branch – both towards Clients and Potential Clients wishing to penetrate the European Market.

Expert Consultant – Laura Mayombo

Sales Department

Laura Mayombo’s career spans 7 years of focusing on Sales and Business Development in the regulatory industry with specific knowledge in cosmetics. She completed a thesis addressing “The Problems in Cosmetics Importation (Europe and China).”

She played different roles in companies like Unilever S.A. & Sally Beauty Holdings, Inc where she took a very detail oriented & meticulous approach, namely in the Hair Care industry.

With a Bachelor Degree in Foreign Trade, great negotiation skills and sales representative experience, Laura joined Obelis to strengthen the Sales Team and help companies on regulatory aspects when selling in the European market.

Consultant (China Branch) – Sabrina Yu

Obelis International Office China

Sabrina Yu joined Obelis with more than 10 years of various experience especially in international quality control and regulatory field. As an Expert Consultant in Obelis China office, she is responsible for advising Chinese manufacturers on regulatory aspects when selling on the European market, allowing them to access new market opportunities in Europe.

She has worked in the Asia leading quality control companies who provide services to worldwide clients as the customer expert, and awards the best employee there. Having worked and lived in Obelis head office, she has great view on EU regulation and culture.