Global Head of Quality and Regulatory Affairs

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.

Key Responsibilities:

• 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.

Key requirements:

• 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.