80
Regulatory Affairs Manager
80 - 100
Description du poste
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 | 80 - 100%
Ref. No. 7829
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.
Contact
Marcel Brader
Human Resources Expert Recruiting
+41 58 234 74 62
Your future place of work
Burgdorf
Regulatory Affairs Manager | 80 - 100%
Ref. No. 7829
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.
Contact
Marcel Brader
Human Resources Expert Recruiting
+41 58 234 74 62
Your future place of work
Burgdorf