Regulatory Affairs Manager
A global Medical Device Company based in Switzerland with ambitious growth plans is currently recruiting for a Regulatory Affairs Manager with proven regulatory skills focused on MDR for their Swiss site.
This Medical Device company requires a consultant to join the team for 12 months fixed contract to successfully work together with the Regulatory Affairs team on implementation of regulatory requirements and field action in accordance with ISO13485, MDD 93/42/EEC, EU MDR 2017/745
- Scientific or engineering studies in the field of medicine
- Minimum 4 years of experience within Regulatory affairs
- Good knowledge of regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU MDR 2017/745
- Experience in quality management and/or product development is an advantage
- Experience in handling document control and/or ERP systems (e.g. SAP) is an advantage
- Proven organisational skill & high level of self-motivation
- Fluent in English and German, any other language would be an asset
Disclaimer: Applicant Must have the Right to Work in Switzerland.