Regulatory Affairs Manager

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)