Regulatory Affairs Associate (Junior position)

Allerød       ·          Full time

Are you looking to kick-start your career within medical devices? Then regulatory affairs are the place for you!

In UNEEG medical, we are specializing in the technology of ultra long-term subcutaneous electroencephalogram (EEG) monitoring contributing to epilepsy management.

We are looking for a Regulatory Affairs Associate to join our Quality Assurance and Regulatory Affairs (QA/RA) department. In Regulatory Affairs, our key focus is to ensure compliance with legislation and guidance for medical devices in order to support our product portfolio and business strategies. We monitor external requirements, prepare regulatory device submissions, and communicate with authorities worldwide.

It is important to us that you are up for a journey with a steep learning curve and are motivated by new challenges at a high pace. To support your professional and personal development, you will get a mentor who, together with you, is responsible for you becoming world-class in regulatory affairs.

Whether you are newly graduated or have a few years of experience within medical devices, our priority is to find a person with the aspirations of learning about regulatory affairs.

Key responsibilities and tasks

• Write regulatory documentation
• Prepare regulatory device files for regulatory submissions
• Monitor external requirements
• Evaluate customer complaints for reportability to authorities
• Provide regulatory assistance and advice to colleagues across the company

What we offer

We offer unique insight into regulatory affairs for medical devices in a position allowing you to grow as the company expands its sales markets. You will be a part of a dynamic and high-performing team, where things sometimes go fast. We solve our tasks with a high degree of professionalism and ambitions. We care for each other, and there is always room for laughter.

About you

You have a BSc, MSc, or Ph.D. degree in a field of natural science such as biomedical, engineering, or similar. You have an interest in understanding legislation and technical aspects of our products, are advanced user in the MS Office package, and have strong verbal and written communicative skills in English and Danish.

On a personal level, you are passionate, eager to learn, flexible, and has a high attention to detail. You are thorough and systematic, and you thrive with driving tasks independently to the finish line.

Application

For more details about the job, please contact Director QA/RA, Camilla Wismar, at +45 40184937.

All application must be in English and are treated confidentially. We will screen and invite candidates for interviews on an ongoing basis, so please send your application and CV as soon as possible.

About UNEEG medical A/S

UNEEG medical A/S is an entrepreneurial and ambitious company specializing in providing the epilepsy community with more accurate knowledge of seizures to support improvement in epilepsy care, ultimately aiming at improving patients’ quality of life. Our unique subcutaneous EEG solution for remote monitoring of brain activity was CE marked in 2019 and our continued international growth and technology roadmap ambitions will require several new functions and competencies in the years to come.

UNEEG medical A/S was founded in 2005 and is today owned by the families behind the large hearing aid company Widex/WS Audiology. We currently employ approximately 110 people in Europe – the majority of these are situated in our headquarters in Allerød, Denmark. Our employees represent various cultures, backgrounds, skills, and years of experience.

Field: QA/RA

Job requirements

• BSc, MSc, or Ph.D. degree in a field of natural science such as biomedical, engineering, or similar
• interest in understanding legislation and technical aspects of our products
• advanced user in the MS Office package
• strong verbal and written communicative skills in English and Danish

Place of work: Borupvang 3450 Allerød

Contact

• Mette Borresen Haugaard HR partner
• Camilla Wismar Manager

Please click here to apply.