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 an interest in and experience 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 clinical development
- Develop systems for «post-market surveillance»
- Monitor and report on the progress of clinical development
- Regulatory and clinical support for global market introductions (eg Japan and FDA)
- Participate in applications for grant financing
We are looking for a candidate with relevant education and experience from working with CROs. Knowledge of 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 teamwork, 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. The working language is English.
The role of Clinical Regulatory Expert is a key role in Otivio. You will be influential in making decisions and have a large impact on the progress of the company. We offer good opportunities for professional and personal development and competitive terms of employment.
Does this sound exciting? Do not hesitate to contact our recruitment partner Head4More, Bjørn Brudevoll, tel +47 468 00 000. Indicate your interest by registering your CV as soon as possible. Information will be handled confidentially also vis a vis current employer.
Otivio is a medtech company based in Oslo, Norway. Our vision is to stimulate active self-care and treatment through simple and easy to use home treatment devices and services. Our product, FlowOx, is CE market and is in the market for the treatment of peripheral arterial disease.
A couple of years ago we made the discovery that FlowOx seemed to have a profound positive impact on key symptoms severely affecting the quality of life of people living with Multiple Sclerosis (MS). Since then, the findings have been confirmed through the first exploratory clinical studies. Multiple Sclerosis is a life altering and incurable neuro degenerative disease that predominantly hits young women, average age at diagnosis is 36 years and 3 out of 4 diagnosed are women. There is an estimated 2.8 million people diagnosed with MS in the world today. We are currently running an extensive clinical programme to document the effects of FlowOx for the treatment of symptoms in people with MS. See www.otivio.com
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