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Regulatory Affairs Manager

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01/07/2024 80% - 100% Permanent position
Work at Ypsomed AG
Ypsomed AG
Regulatory Affairs Manager

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 | Hybrid

Help 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)
Ypsomed - making the treatment of chronic diseases possible

More than 2,000 employees worldwide develop and produce injection and infusion systems for self-medication with the Ypsomed Group. We are a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. With our market-leading products and solutions, we enable people all over the globe to self-treatment. Despite chronic diseases such as diabetes, obesity, or certain types of cancer, they are provided with the greatest possible quality of life.

Contact

Alain Rusconi
Human Resources Expert Recruiting

+41 (0) 34 424 28 64

Your future place of work

Solothurn

Place of work

Ziegelmattstrasse 1

4500 Solothurn


About the company

2,7 (14 reviews)

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