regenold GmbH is privately owned by Dr. Jürgen Regenold and his family.
Jürgen supports as Chairman the Management Board of newly appointed Managing Directors, who have been promoted internally, to ensure continuity in the business and the servicing of our clients. Jürgen will also continue to be involved in strategic aspects of the business to ensure it develops to serve the needs of our clients, now and in the future.
Jürgen has an extensive background in the pharmaceutical industry and has mastered his pragmatic and constructive approach through many years of industry and consultancy expertise.
Chairman
After receiving his university degree in pharmacy in 1986, Jürgen spent four years conducting pharmacological research on CNS pre-synaptic transmitter-receptor interactions. Beginning in 1990, he worked on both the management and regulatory of pharmaceutical product development and established regenold GmbH in 1994.
In 1996, Jürgen began identifying resources and regulatory expertise in selected European countries which, in 2001, led him to establish regulanet®, a global network of independent, collaborative partners.
Jürgen has led and managed the growth of regenold GmbH and CE plus, the medical device division, into a full-service international consultancy with more than a hundred fully qualified employees.
Managing Director
Marcel joined regenold GmbH in 2009 as a Regulatory Affairs Expert and has worked since 2011 for CE plus, the medical device division.
Marcel has over 12 years of experience as a Regulatory Affairs Expert in the fields of non-active medical devices, drug registrations (CMC – Chemistry, Manufacturing & Control), auditing relating to EN ISO 13485 and ISO 17025 and the establishment of quality management systems according to EN ISO 13485. Specialized in supporting CE marking for substance-based medical devices (borderline products) and combination products (drug device and device drug), Marcel successfully managed the non-active medical device team.
During the last three years, as leader of the team, he has developed services ranging from compilation of technical documentations for all risk classes and product development throughout the entire process including CE-marking and beyond. As Managing Director, Marcel contributed to the establishment and growth of our affiliated company, NEXTEC medical GmbH, which can assume the legal responsibility for Medical Devices and In-Vitro Diagnostics in the market. In July 2021, he was appointed Managing Director with responsibility for Active and Non-Active Medical Devices, In-vitro Diagnostics, Preclinical Strategy & Development and Data Science & Analytics.
As a medium-sized multinational company with more than 100 employees from 14 nations around the globe, we strive to create and maintain a diverse and positive working environment for every employee at regenold GmbH. We believe in the individual potential of all our employees and it is through their knowledge, experience, and eagerness to take on challenges that we continue to offer personalized solutions to unique problems for all our clients. Come join us today.
