We are delighted to welcome our new Head of Regulatory & Clinical to the Congenius team.
Bruno Gretler joins us with 20 years of experience in the medical devices and IVD sector, 17 of which were acquired in regulatory affairs at Medela, Nobel Biocare, and most recently at Roche Diagnostics in Rotkreuz.
During his time at Roche, Bruno spent six years as RA Manager and Functional/Team Lead in Regulatory Affairs. In this role, he actively supported the launch of several new products including IVD instruments, laboratory devices, and software in the major markets worldwide, and drove the implementation of the IVDR. Bruno then worked as a Solution Portfolio Manager, closely collaborating with international business leaders, product managers, and engineers to develop and drive innovative e2e solutions that were successfully launched on the market. During this role, he initiated and supported regulatory and business strategies based on market needs and solution design.
Congenius CEO Jörg Dogwiler commented, “Bruno’s robust regulatory expertise and wide-ranging experience make him an excellent choice to take the helm of our Regulatory and Clinical departments. With a vast career spanning the engineering, quality, and regulatory fields, Bruno brings with him the kind of diverse knowledge and insights needed to help our customers with their ever-evolving MedTech challenges.”
A strategist, people manager, and global compliance expert, Bruno has been responsible for numerous successful regulatory submissions and internal audits, as well as the development of effective quality management systems, medical device software, and product life cycle management processes.
On joining the team, he said: “I’ve been very fortunate to work on a range of medical devices and IVDs at exciting and pioneering companies. I am now ready to take on this fresh challenge and look forward to contributing my experience to the further development of the Regulatory and Clinical departments, and working with the knowledgeable consultants at Congenius.”
Jörg added: “We are really happy to welcome Bruno, and anticipate that his hands-on, pragmatic, and achievement-oriented outlook will help drive the expansion of our Regulatory and Clinical offering.”
Find out more about our Regulatory services here, and for more about how we can support with Clinical Affairs challenges, see here.
