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Regulatory Affairs Professional

Medical device Regulatory Professional – with an eye for biocompatibility

UNEEG medical A/S is looking a RA professional to a newly established position in their QA/RA team. As our new RA professional, you will be responsible for various regulatory tasks with a dedicated focus on the area of biocompatibility.

UNEEG medical A/S is pioneering in cognitive technologies designed to help and empower patients. We create tiny implants that monitor and analyze brain activity (EEG) to convey relevant information and issue alerts. www.uneeg.com

We have recently launched our first product solution for our Neurology/epilepsy market and as RA professional your will have a key role in transferring our products to be EU-MDR complaint.

The position offers an extraordinary opportunity for the right candidate to join a company “on the move” and make significant difference for both company and patients.

Your responsibilities:

Develop and execute regulatory strategies for new and existing products
Develop and maintain regulatory documentation/records
Prepare documentation for Regulatory submissions in EU and USA
Manage and coordinate biocompatibility and chemical characterization testing
Participate in post market surveillance processes
Contribute to the continual update of knowledge on regulatory requirements and contribute to incorporating these requirements in the quality system e.g. EU MDR and US FDA QSR
Contribute to the continuous development of processes and documentation with QA/RA.

You have qualifications within:

Educational background within Engineering, healthcare sciences and a like
Preferably 3 years of experience from Regulatory affairs in a medical device setting – beneficially would be active medical implants and Software as Medical Device (SaMD)
Experience with regulatory submissions for medical devices in EU and USA. Experience with 510(K) premarket notifications would be preferred.
Solid knowledge of Regulatory legislation, standards and guidelines including EU-MDR, ISO 13485, US FDA Quality System Regulation (QSR)
Familiar with Design Control and Biocompatibility (ISO 10993)

The Personality we are looking for:

At UNEEG Medical A/S we are looking for team members that thrive through an independent and ambitious work environment, where your curiosity, willingness to learn and a can-do attitude are used to benefit the team and reach our common goals.

If the above sounds like a challenge you are up to, and you see yourself adding to a fast-growing company please feel free to reach out for more information or sent an application via www.pharmarelations.com.

For more information contact Head of recruitment PharmaRelations Ida Wenger-Parving at mail: ida.parving@pharmarelation.dk or at + 45 2633 4301.

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