We are delighted to welcome our new Head of Regulatory to the Congenius team.
Corinne Larke joins us following over a decade in Regulatory Affairs at Stryker in the US. During her role as a Regulatory SME for Digital Health and Personal Protective Equipment, Corinne gained robust experience in both a strategic and managerial capacity – taking responsibility for the creation and implementation of effective regulatory strategies for new products, and leading successful regulatory submissions and audits for the EU and US markets.
As Regulatory Lead for Stryker’s EU MDR transition, she successfully recruited and managed the EU MDR team, provided compliance guidance to cross-functional teams, steered the EU MDR gap analysis, guided process owners in QMS updates and managed the company’s MDR readiness audit.
Congenius CEO Jörg Dogwiler commented, “Congenius built its foundations in Regulatory Affairs, and this field remains an important pillar of our service offering to customers. Corinne’s flair for leadership and solid regulatory expertise make her an excellent choice to head up our growing Regulatory department.”
Basel-born Corinne brings with her a strong background in political science (with a Master’s in Governance from the University of Hagen), and over 12 years’ experience in the medical device industry spanning pre- and postmarket regulatory affairs as well as quality management systems.
On joining the team she said, “Coming on board with Congenius provides the perfect opportunity to apply my passion for establishing meaningful relationships and driving innovation in the compliance area. It’s great to be joining a truly authentic organisation and I’m excited to get started.”
Jörg added: “We are so happy to welcome Corinne. I have no doubt that her varied experience, creativity and solution-oriented approach will help drive forward the further expansion of our Regulatory team.”
To find out more about our Regulatory services, click here.