Regulatory Affairs Manager

vor 24 Stunden

Kanton Solothurn, Schweiz Ypsomed Vollzeit

At our site in Solothurn in the field of Regulatory Affairs, we are looking for an experienced and motivated personality as a

**Regulatory Affairs Manager**:
**Ref. No. 3589**:
**Regulatory Affairs Manager**:
**Your main tasks**:

- Focus of this position is supporting our single-use sterile medical devices
- Support and prepare product submission documents with main focus on USA, Canada, and EU
- Prepare regulatory strategies
- Support of development projects with a focus on regulatory aspects
- Evaluation of change requests
- Review quality agreements with customers on regulatory aspects
- 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 5 years of professional experience in Regulatory Affairs with focus medical device
- Previous experience with sterile medical devices, e.g. ISO 11135, 11137, 11607, 10993 ff. a plus
- Experience with US, CAN and EU registration
- Strong organizational skills and high efficiency
- Ability to communicate effectively with different stakeholders and on different levels
- Very good English knowledge (Level C2 or MT)
- Good German knowledge (Level B1 or B2)

**Your perspective**:
With us you will find interesting job content, promising development opportunities and attractive employment conditions. We offer you the prospect of helping to shape the innovation-driven and quality-oriented world of medical technology.

**Your benefits**:
Holidays

Work time

Mobility

KTG UVG

Pension fund

Loyalty bonus

**Contact**:
**Jan von Felten**
Human Resources Consultant

Your future place of work

+41 (0) 34 424 46 77

**The Ypsomed Group**:
The Ypsomed Group is a leading developer and manufacturer of injection and infusion systems for self-medication and a renowned diabetes specialist with over 30 years’ experience. Ypsomed has its headquarters in Burgdorf, Switzerland, and operates a global network of manufacturing sites, subsidiaries and distributors. The Ypsomed Group employs around 1800 employees.

**Company presentation**:
Ypsomed is a leading developer and manufacturer of injection and infusion systems for self-medication and a renowned diabetes specialist.

**Further information**:

- Our Company
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