Location: Geneva, Switzerland
My client is a global medical device company, headquartered in Geneva, Switzerland, specialising in implantable medical device products and are looking for a Global Head of Quality and Regulatory Affairs. Given that they are in strong phase of growth with an exciting pipeline, they are looking to consolidate the QARA department.
- Defining the Regulatory strategy and establish regulatory compliance of many independent legal manufacturers.
- Oversee due diligence conducted from a QARA point of view and managing Post merger integration activities to establish business continuity.
- Prepare and manage several successful international inspection.
- Responsible for implementation for the MDR regulation (EU).
- Responsible for Global regulatory compliance strategy for high-risk implantable device including FDA 510(K) and PMAs.
- Oversee the responsibility of the QARA team.
- Bachelor's Degree or equivalent experience.
- 10+ years' experience in Quality Assurance and Regulatory Affairs.
- Extensive experience with implantable medical devices.
- Experience with MDR and FDA submissions, both 510k and PMAs.
- Regulatory experience outside of EU/US (e.g. Latin America, Asia…).
- Experience in managing a team of 10+ people.
- Fluent in English.