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 – 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
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
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
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
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
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.