Job description

LIITA Care ApS offers a unique and dynamic opportunity for qualified individuals who are interested to grow their knowledge and experience within regulatory affairs in the Pharma- / Medtech industry. LIITA is looking for a regulatory assistant that can provide support in preparing documents for our technical dossier and quality management system along with executing the advice of our regulatory advisors. We are in the process of registering our product, BREATHOX®, in the EU. Main task will be to assist in preparing our technical dossier for registration in the EU, and in key regions around the world.

Company description

LIITA Care is a med-tech start-up focused on respiratory health. We are committed to improve quality of life for patients and healthy consumers by developing and manufacturing new and better therapies and medical devices for respiratory health management. Our product BREATHOX® is currently marketed in Northern Europe and we plan to expand to global coverage in 2023. We are currently negotiating with multiple potential commercial partners – and it is this process that we are now offering you to become a part of by contributing to the regulatory registration in different countries globally.

The position

You will be primarily responsible for assisting the external RA/QA team in preparing regulatory documents and updating the technical file before the notified body audit end of 2022. Parallelly, you and the RA/QA team will also be working on preparing the dossier for submission to the FDA and the ANVISA. You will provide support by being in charge of specific annexes and also be part of the organizational team that drives the registration process and ensures quality of the technical file while maintaining compliance with SOPs from the QMS. The required tasks will take place in the LIITA Care office located in Copenhagen K.

Qualifications

We expect you are a recent graduate with an emphasis on production engineering, pharmaceutical science or law. You need to possess knowledge of EU MDR 2017/745. We also need you to have strong communication skills in English in order to assist in preparation of the dossier and communicate with our regulatory partners. It is important that you have the ability to work independently and have a quality mindset. You should further have a genuine interest in working in the field of medical devices and regulatory affairs. Relevant experience in the field is highly desirable, but it is not a requirement.

Details

Full-time internship, 37 hours per week, open-ended, with flexible schedule. Salary is 12 000 DKK/month

Deadline

Ultimo August 2022. We will review applications on an on-going basis and will conduct interviews whenever a suitable candidate is identified. For more information about the product and company, please visit our website www.liitacare.com