Regulatory Affairs Manager

Vor 6 Tagen

Kanton Solothurn, Schweiz Ypsomed Vollzeit

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

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

- 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**:
You will find a fascinating work environment, good development opportunities as well as attractive employment conditions and a modern working model with flexibility. We offer you the opportunity to help shape the innovation and quality-oriented world of digital solutions in medical technology.

**Your benefits**:
Holidays

Work time

Mobility

KTG UVG

Pension fund

Loyalty bonus

**Contact**:
**Jan von Felten**

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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