Regulatory Affairs Manager

vor 2 Wochen

Solothurn, Schweiz Ypsomed Vollzeit

In the Business Area Diabetes Care in Solothurn we are looking for an experienced skilled personality as a

**Regulatory Affairs Manager | **100%**:
Ref. No. 6448
- 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 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 US
- Partner with business stakeholders on different levels
- 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 4 years of professional experience in Regulatory Affairs with focus medical device
- Expertise in Active Medical Devices related regulations and guidance documents in EU and US
- Excellent organizational and people skills
- Very good English knowledge (Level C2 or MT)

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