Clinical Regulatory Expert
Do you want to be part of a highly motivated team with the ambition to impact the quality of life of a highly underserved patient population? We are at a good pace of entering the market with a unique product that has the potential of disrupting the treatment of MS symptoms. If you have the interest for and the experience from working with regulatory and administrative aspects of clinical trials, we would like to talk with you.
As the Clinical Regulatory Expert you will work closely with the Head of Quality and Regulatory, the Head of Medical Affairs and the Chief Scientific Officer, as well as the rest of the team being located in Norway, Germany and Denmark. In close cooperation we plan, develop and implement clinical strategies. We are currently conducting local and international studies in the MS field and are looking to do additional studies in the near future.
Main areas of responsibility include:
- Selection of and cooperation with CROs and other clinical development partners.
- Document internal processes related to clincial development
- Develop systemes for «post market surveillance»
- Monitor and report on progress of clinical development
- Regulatory and clincal support for global market introductions (eg Japan og FDA)
- Participate in applications for grant financing
We are looking for a candidate with relevant education and experience from working with CROs. Knowledge with ISO 13485, ISO 14155, GCP and MDR is preferable, but experience with other quality systems is also relevant. If you prefer quick decision making, a cross functional approach and team work, you would thrive with us. Others would describe you as proactive, targeted and curious. We value good social skills, flexibility and the ability to build relations. Working language is English.
The role as Clinical Regulatory Expert is a key role in Otivio. You will be influencial in making decisions and have a large impact on the progress of the company. We offer good opportunities for professional and personal development and comptitive terms of employment.
Startdate after mutual agreement, but preferably January 1st, 2023.
If you have questions or are interested in hearing more about the position, please contact Siril Skogbrott, firstname.lastname@example.org, +47 41361473
Please apply here!
A bit about us:
FlowOx is a class IIa medical device, originally developed for treating blood flow deficiency in patients with peripheral arterial blood flow disease.
Otivio is a MedTech development company headquartered in Oslo, Norway and with subsidiaries in Denmark, Copenhagen and Germany, Munich.
Read more about Otivio and FlowOx on www.flowox.com or contact Claus Kjærsgaard. m: +45 5384 9718; e: email@example.com