Description
We are looking for a
Regulatory Affairs Manager (m/f)
Reference: -en
Start: ASAP
Duration: 10 MM+
Place: in Central Switzerland/the Swiss Plateau region
Branch: Pharmazeutische Industrie
Your tasks:
- Provide regulatory support to the R&D Project teams with the applicable Design Control/Design Quality processes
- Provide qualification and classification of the development object and related submission strategy
- Review of labelling and assembling of the documents and the project deliverables (or coordinating the activities) for the preparation of world-wide registrations and changes for three various product lines
Your qualifications
- University degree with a focus on either natural sciences or engineering
- Regulatory/Design Quality experience in Medical Devices for software and instruments
- Good understanding of IVD products and the related regulatory activities and requirements
- Outstanding English skills in both verbal and written form (German is beneficial)
Skills:
- Regulatory affairs manager