Regulatory Affairs Manager (m/f/d)
Solothurnerstrasse 235, Switzerland | Olten | Full-time
Stellenbeschreibung
- Accompanying development projects from the feasibility phase to the timely approval of products in international markets
- Preparation of regulatory strategies for the approval of products in different markets
- Collaboration with the disciplines R&D, Product Management, Medical Affairs, Industrialization and Quality
- Preparation and maintenance of regulatory documents such as intended use, classification, list of applicable regulations and standards, essential principles
- Collaboration with regulatory partners at customers and suppliers, authorities and conformity assessment bodies
- Registration of products worldwide; recertifications of products
- Approval of products worldwide; recertification of products
- Assessment, documentation and communication of changes to authorities and conformity assessment bodies
- Representation of regulatory requirements in the company (MDR, US and global requirements)
- Supporting further development of regulatory processes in the quality management system
Qualifikationen
- Successfully completed scientific or engineering studies (or comparable education)
- Profound experience and knowledge in Regulatory Affairs for medical devices (drug-delivery devices, active and connected medical devices would be an advantage)
- More than 3 years' experience in the approval of products in the US, Canada and EU (further markets desirable)
- Pleasure in goal-oriented writing and reviewing of documents
- Systematic, quality-oriented and well-documented working method
- Team player with strong analytical skills who is proactive and solution-oriented
- Dedication and excellent communication skills
- Fluency in German and English
Zusätzliche Informationen
We offer a challenging, international environment and the opportunity to actively contribute to the company and different teams with knowledge and engagement, and to develop personally. We also offer a modern workplace in a historic building, advanced and flexible working conditions as well as salaries according to performance and well-developed social benefits.
Interested? Please upload your complete application (letter of motivation, CV, job references, diplomas / certificates) by clicking on the "apply now" button. We look forward to reading from you.
Your contact person - For further information please contact Mr. Alen Behric, HR Generalist, +41 62 209 71 00
