07 Oct

Regulatory Affairs Manager

Burgdorf

Descripción

MyLife 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. No

Location: Burgdorf | Hybrid

Help us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach.

Your main tasks

Focus of this position is supporting our rapidly developing in Diabetes Care (active and connected devices)
Manage the development and implementation of RA strategies
Support and prepare product submission documents with main focus on US
Partner with business stakeholders on different levels
Communication and correspondence with authorities
Cooperation in authority audits
General QM tasks (Creation of Q-documents, trainings etc.)

Your profile

University degree preferably in Engineering or Natural/Medical Sciences or equivalent experience
At least 5 years of professional experience in Regulatory Affairs with focus medical device
Expertise in Active Medical Devices related regulations and guidance documents in US
Excellent organizational and people skills
Strong team player
Strong communicator at a high stakeholder level
Very 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.