Regulatory Affairs Manager
vor 2 Wochen
In the Business Area Diabetes Care we are looking in Solothurn for an experienced skilled personality as a
**Regulatory Affairs Manager | **80 - 100%**:
Ref. No. 6536
- Location:
- Solothurn- | HybridHelp 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 regulatory strategies
- Support and prepare product submission documents with main focus on EU and Canada
- Partner with business stakeholders on different levels
- Support life-cycle management activities
- Communication and correspondence with authorities
- Cooperation in QMS ISO 13485 and 21 CFR 820 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 2 years of professional experience in Regulatory Affairs with focus medical device
- Expertise in Active Medical Devices related regulations and guidance documents in Europe and Canada
- Excellent organizational and people skills
- Very good English knowledge (Level C2 or MT)
- Good German knowledge (Level B1 or B2)
-
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