LIITA Care ApS offers a unique 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 junior project manager that can support the development of our technical dossier and quality management system. The job is closely connected to our highly prioritized project of registering our product, BREATHOX®, in the EU under the Medical Device Regulation (MDR).
You will be working closely with the management to create a project plan and execute on preparing our technical dossier and registration in the EU, and later in other key regions around the world..
LIITA Care is a consumer health 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 globally in the years to come.
You will be primarily responsible for coordinating our internal regulatory project and support our cooperation with external RA/QA professionals.
Your main tasks would be to prepare regulatory documents and updating the technical file before the notified body audit end of 2023. 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 the 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.
You are studying for your master's or 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 the 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.
February 15 2023. 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.
This job comes with several perks and benefits
Time is precious. Make it count. Morning person or night owl, this job is for you.
Get your caffeine fix to get you started and keep you going.
Easy access and treehugger friendly workplace.
We want to take you from good to great.
Carve out time for your kids, friends and personal cider projects.