Regulatory Affairs Specialist -MDR

Regulatory Affairs Specialist -MDR

Our client is a leading international company operating in a complex and highly regulated environment and is currently looking for a Regulatory Affairs Specialist -MDR for a renewable temporary assignment.

Description du poste

• Under supervision, coordinate, compile, and submit regulatory applications to competent authorities, notified bodies, regulatory agencies, and international business partners, including the preparation of key market international documents, including technical files.
• Work with Regional Head of Regulatory Affairs to ensure rapid and timely approval of new products and continued regulatory support of products marketed within and outside the Europe, including labelling guidance and adequate deliverables required for technical file and MDR requirements.
• Work to support and ensure regulatory compliance across Europe for a broad product portfolio including medical dev...