Davide Turchi is an experienced Regulatory Affairs / Quality Assurance Consultant and ISO Officer, with a demonstrated history of working in the medical device, IVD, Cosmetics, Machinery EU compliancy field.
With a strong legal background and skills in public speaking, teaching and mentoring, management and leadership, Davide currently occupies the position of Expert Consultant in Obelis’ Regulatory Department.
Martina is Deputy Manager of our VIP Department and Regulatory Affairs Expert with extensive experience in the field of Medical Devices and Cosmetics.
Her background in International Relations and Internationalization Strategies for SMEs informs her regulatory-based approach, attentive to both compliance and business needs.
Before joining Obelis in 2017 Martina has studied and worked in Italy, the UK, Spain and gained experience in EU regulatory affairs at the EU Commission in the sector of Internal Market, Industry, Entrepreneurship.
Deputy Manager - Research & Development
Floriana Dibitetto holds a Master’s Degree in European Studies from the European College of Parma, and she is a Regulatory Affairs Expert dealing with medical devices, cosmetics and CE marked products.
As Deputy Manager of the R&D department, Floriana is focused on developing and implementing Obelis services to ensure a high-level consultancy to customers, as well as on managing Obelis’food supplement service.
Prior to joining Obelis in 2016, she gained experience in EU regulatory affairs at EU Commission and EU Parliament dealing with food information to consumers.
Deputy Manager - Post Marketing Activities
After studying Law at the University of Warsaw, Szymon Nowak-Rogozinski completed his studies at the European School of Law and Administration and obtained a Master's Degree in Law.
At Obelis, Szymon is is currently the Deputy Manager of the Post Marketing Activities Department, therefore he is responsible for handling and coordinating all Vigilance and Post Marketing Surveillance cases.
Ajda Mihelčič joined Obelis Regulatory department in 2017 to assist clients through EU compliance process, and is Deputy Manager of Publications department since 2019 supervising all regulatory content externally published, and ensuring timely circulation of regulatory developments.
Ajda graduated from law at University of Ljubljana and holds an Advanced Master’s degree from Saint-Louis University Brussels. She has been gathering experiences at the European institutions, in the international judiciary and in the non-governmental branch. Regulatory affairs, namely medical device sector, were her main focus in the past years, while managing Information Platforms MDlaw.eu since its creation as well as COSlaw.eu.
Ajda is native Slovenian with fluency in English and French, and is improving her Italian. She is passionate about law and firmly believes in the European project.
Quality Management System Department
Roland Gerard is a Regulatory Affairs Expert with 30 years of experience in the field of high risk implantable medical devices: he 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. He also has extensive experience in CE marking and in dealing with competent Authorities and Notified Bodies.
Senior Expert & 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.
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.
With a Bachelor’s Degree in Foreign Trade, great negotiation skills and Sales Representative experience, Laura Mayombo joined Obelis to strengthen the Sales Team and help companies on regulatory aspects when selling in the European market.
Her career spans 7 years of focusing on Sales and Business Development in the Regulatory Industry with specific knowledge in cosmetics.
As a Senior Consultant, José Amsing is responsible for advising companies on regulatory aspects when selling in the European market, allowing them to access new market opportunities in Europe.
Her professional experience involves expertise in both the private and public sectors. Having worked and lived in different countries (such as USA and the Netherlands), she has developed a broad knowledge on Sales and Business Development.
Marika Zielinska holds the Senior Consultant position at Obelis, with almost a decade of expertise in EU Regulatory Affairs. She played a pivotal role in the creation and establishment of Obelis’ new Sales Department as it stands today.
Due to her understanding of EU regulatory requirements, Marika also serves as the Training Officer within Obelis Sales Department, responsible to create and deliver regulatory trainings, online or on-site.
Shikha Malhotra is a Senior Consultant at Obelis, her career spans over 13 years. Shikha, possess a successful history of enabling companies, solve complex problems in a simplistic way. Over the years Shikha has advised clients from all continents in various industries. In doing so she has gained a privileged insight in the functioning of many different business models allowing her to provide tailor-made advice. She will be delighted to help you navigate the maze of regulation to attain EU & UK compliance and consistent access to those markets.
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.
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.
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.
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, and currently holds the position of Customer Relations Deputy Manager at Obelis.
As a Clients Relations Expert Consultant, Mathias is a firm liaison between the Obelis Regulatory Team and our clients.
Siana Slavova holds a Master's Degree in Tourism Management from the Catholic University in Milan. She has completed executive programs in Marketing and Management and is an MBA graduate awarded with distinction from the Warwick Business School.
With more than 10 years of international experience in service-oriented organizations, her expertise lies in customer analytics, operational and strategic marketing, project management, business planning and strategy development. She has joint Obelis' team in 2019.
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 and she currently holds the Expert Consultant position in Obelis’ Administration Department.
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.
Before joining Obelis, where she occupies the position of Expert Consultant in the Human Resources Department, Patricia had gained several years of international HR experience in four different countries.
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