Regulatory Affairs Manager

Noventure is a Spanish company based in Barcelona, specialized in licensing innovative substance-based medical devices and specialized food supplements. We offer approved medical devices under CE Mark ready for marketing in UE as well as in other territories around the World, and high standard food supplements supporting physiological functions in Gastroenterology, Urogynaecology, Paediatrics & Dermatology areas.

Your mission 

The Regulatory Affairs Manager will be responsible for managing and coordinating the registers of Noventure medical devices and medicines.

Responsibilities

• Coordination and follow-up of marketing authorization applications for medical devices, drugs and food supplements. Submission of renewals and variations of existing marketing authorizations. Preparation and review of the necessary documentation.
• Regulatory support to licensees and other Departments of the Company.
• Maintenance of the Department's database.
• Review of Technical Data Sheets, leaflets, labeling and mock-ups.
• Communication of launching in the European Union.