Regulatory Affairs Manager

Vor 2 Tagen

Kanton Solothurn, Schweiz Ypsomed Vollzeit

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

**Regulatory Affairs Manager**:
**Ref. No. 4405**:
**100%**:
**Regulatory Affairs Manager**:
**100%**:
**Your main tasks**:

- Accountable for the definition of regulatory strategies and the preparation of submission documents of reusable pen injector medical devices to worldwide regulatory authorities with a particular focus on EU and USA
- Act as Regulatory Affairs expert within development projects
- Manage Lifecycle Management activities
- Correspondence with customers and authorities
- Ensure regulatory and organizational compliance with all applicable regulations, standards and internal policies
- Support of QMS ISO 13485 and 21 CFR 820 audits
- Contribute to departmental projects and tasks

**Your profile**:

- Higher education or equivalent experience
- Proven track record of professional experience in Regulatory Affairs with focus medical device
- Ideally experience in software as a medical device and digital health preferred
- You enjoy working in an international, diverse and cross-functional organization
- You are a team-player with excellent organizational and communication skills, demonstrating a learning mind-set
- Your profile is completed by good German (B1) and English (B2) knowledge

**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**:
**Irene Molnar**
Human Resources Manager

Your future place of work

+41 (0) 34 424 33 19

**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 35 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 1900 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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