Regulatory Affairs Manager

Regulatory Affairs ManagerMyLife Diabetes Care AG is a new, independent medtech company specialising in the treatment of diabetes using advanced insulin pump systems. To strengthen our Quality Management department, we are looking for a very experienced person on a high seniority level for our Diabetes Care Business in the B2C sector at our new Headquarter in Burgdorf.Regulatory Affairs Manager |%Ref. NoLocation:Burgdorf | HybridHelp us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach.Your main tasksFocus of this position is supporting our rapidly developing in Diabetes Care (active and connected devices)Manage the development and implementation of RA strategiesSupport and prepare product submission documents with main focus on USPartner with business stakeholders on different levelsCommunication and correspondence with authoritiesCooperation in authority auditsGeneral QM tasks (Creation of Q-documents, trainings etc.)Your profileUniversity degree preferably in Engineering or Natural/Medical Sciences or equivalent experienceAt least 5 years of professional experience in Regulatory Affairs with focus medical deviceExpertise in Active Medical Devices related regulations and guidance documents in USExcellent organizational and people skillsStrong team playerStrong communicator at a high stakeholder levelVery good English knowledge (Level C2 or MT)Together, we create solutions that improve lives.At mylife Diabetes Care, we develop integrated solutions that people with diabetes can truly rely on.We are a fast-growing, family-owned company headquarterd in Burgdorf (Switzerland) – built on 40 years of innovation and active internationally.We bring together expertise, dedication and a clear mission: empowering people to gain more freedom through better control.Everything we do is developed with purpose and designed with care.Our core competence lies in automated insulin delivery (AID). With mylife Loop, we provide a system that adapts to the individual needs and everyday lives of people with diabetes.ContactMarcel BraderHuman Resources Expert Recruiting+41 58 234 74 62Your future place of workBurgdorf jid372f56fpn jit0207pn jiy26pn