Regulatory Affairs Manager
Auf einen Blick
- Veröffentlicht:09 September 2024
- Pensum:80 – 100%
- Vertrag:Festanstellung
- Sprache:Englisch (Fortgeschritten)
- Arbeitsort:Solothurn
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
Kontakt
Ypsomed AG