Anette Schafer is a seasoned Regulatory Affairs Project Manager at Roche Diabetes Care, where she plays a pivotal role in ensuring compliance with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) for the company's extensive product portfolio. With over 11 years of...
Anette Schafer is a seasoned Regulatory Affairs Project Manager at Roche Diabetes Care, where she plays a pivotal role in ensuring compliance with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) for the company's extensive product portfolio. With over 11 years of project management experience, Anette has honed her expertise in navigating complex regulatory landscapes, particularly in the context of Accu-Chek® products, including insulin pumps and infusion sets, as well as Continuous Glucose Monitoring (CGM) systems.
In her current role, Anette is responsible for the product re-registration process, which involves meticulous coordination with German authorities to secure necessary approvals and declarations of conformity. Her deep understanding of regulatory requirements, coupled with her strong project planning and risk analysis skills, enables her to effectively manage cross-departmental teams and drive projects to successful completion. Anette's strategic planning capabilities are complemented by her proficiency in tools such as Microsoft Project and SAP, which she utilizes to streamline project workflows and enhance team collaboration.
Anette's commitment to continuous improvement is evident in her involvement in infrastructure projects aimed at optimizing project management training and tools within the organization. Her ability to lead change management initiatives and foster a culture of compliance and quality assurance makes her an invaluable asset to Roche Diabetes Care. With her extensive knowledge and soft skills, Anette is well-equipped to tackle the challenges of the evolving regulatory environment, ensuring that Roche's innovative diabetes care solutions remain at the forefront of the industry.
