Regulatory Affairs Specialist

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.

Responsibilities

• Coordinate, compile, and submit regulatory applications to competent authorities, notified bodies, regulatory agencies, and international business partners, including preparing key market international documents and technical files.
• Work with the Regional Head of Regulatory Affairs to ensure rapid and timely approval of new products and to provide continued regulatory support for products marketed within and outside Europe, including labeling guidance and delivery of required technical files and MDR documents.
• Support and ensure regulatory compliance across Europe for a broad product portfolio including medical devices, consumer packaged goods, and cosmetics.
• As...

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