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Senior Regulatory Affairs Professional

Advokat i Nordsjælland

PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders.

Senior Regulatory Affairs Professional

As our new Senior Regulatory Affairs Professional, your main responsibility will be to ensure regulatory strategies for new products and changes to existing products are performed according to project plans. Further, you will have a key role in implementing the Unique Device Identification (UDI) requirements and upload data to EUDAMED, when available.

Our first product solution for monitoring and analysing brain activity (EEG) aimed at improving the lives of fellow humans, impaired by epileptic seizures is available on the European market. The product portfolio consists a sterile active implant, a sterile insertion tool and a recorder that communicates with the implant. Further, we have software products for transfer of data. The products are developed under the directives for active implantable medical devices and we are currently in transition to the European Medical Device Regulation (MDR), where the devices mainly will be of class III.

The department:

You will be joining 7 highly dedicated and skill...