Well respected client requires a dynamic consultant to join the MDR project team. You will be responsible for all MDR related Regulatory tasks for their products.

The required activities include showing an Authorised Representative on all our product labelling, a national product registration and establishing an economic operator.

Duties

• Independent execution of the Regulatory activities (approving content) for the over label activities for the client
• Independent product registration for the client in the new national Regulatory framework
• Independent establishing of an economic operator regarding the required Regulatory activities,
• Elaborate Authorised Representative Agreement with cross functional teams and routing for final signature
• Supporting relevant SOP updates by reviewing initial draft, coordinating internal feedback, liaising with cross functions
• Knowledge on MDR regulations

Experience

• 2-4 Years Reg affairs Medical Devices
• MDD/MDR essential

Please contact Phil Turner or email your resume for an immediate response