We have the pleasure of working with one of the world leading medical device organisations and we have been asked to source a Senior Regulatory Affairs Specialist EMEA for one of their divisions. The main objectives of the role will be to contribute to successful business goals by supporting regulatory activities linked to pre and post-market clinical studies, as well as all associated reporting in the EMEA region.

Key Responsibilities Include but not limited to
 

• Establishing, managing and maintaining good relationships with the local regulatory authorities in the region
• Interacting directly with regulatory authorities personnel for clinical study related activities, for all business units.
• Coordinating the preparation, review and submit timely clinical study files from the first submission to the closure of the studies.
• Design and maintain tracking tools for the clinical activities.
• Support regulatory advocacy activities in the region and local medical devices industry working groups when related to clinical studies

To be considered for this position individuals must be degree educated and have at least 5 years regulatory experience with a minimum of 3 years spent working within the medical device sector.

You will need to demonstrate a good understanding of EU medical device regulations and clinical studies in medical devices, pharmaceutical clinical study experience is an advantage plus you will need to have prior experience working directly with the regulatory bodies.

This is an excellent opportunity to join a dynamic and growing organisation in a role which will place you at the heart of a global regulatory function.