To ensure continued clinical expertise as an integrated part of the lifecycle of our medical device portfolio, we are looking for a medically qualified colleague.
As a Medical Advisor - jointly assigned to Medical Affairs and Regulatory Affairs, you will join our team of 30 dedicated colleagues in Denmark, including one Medical Advisor. Internally, the Medical Advisors work closely together with colleagues of our Product Development, Clinical Affairs, Quality Assurance, Quality Engineering, and Marketing departments, and externally, with colleagues of the global Medical Affairs team and other Cook sites.
This position will primarily provide internal support to the Vascular Division of Cook Medical, which includes Aortic Intervention, Critical Care, Interventional Radiology and Peripheral Intervention. You can learn more about our Medical Divisions at www.cookmedical.eu.
Your main responsibilities as a Medical Advisor will be:
- Building and maintaining medical knowledge of William Cook Europe’s product lines, both for new and existing products, and the clinical procedures for which they are used
- Having a clinical understanding of the risks, benefits, patient selection and treatment options for the appropriate disease groups
- Working closely with Regulatory Affairs, Quality Engineering, and Quality Assurance to assess the relative risks and benefits of William Cook Europe’s devices throughout the product life cycle
- Assisting in identifying clinical evidence gaps related to William Cook Europe’s technologies, contributing to clinical trial design where relevant, and contributing to the review of Clinical Evaluation Reports
- Providing clinical evaluation as part of the vigilance process
- Providing clinical input and review of device risk assessments and Post Market Surveillance activities
- Providing critical clinical review of documents such as product labeling, marketing, training, and educational materials
- Providing clinical experience and support to Regulatory Affairs, Quality Assurance, Quality Engineering, Clinical Affairs, Marketing/Division, and other internal groups and processes as needed
- Contributing to and aligning medical aspects within the Cook Global Medical Affairs function.
As a Medical Advisor, you are expected to have the following qualifications:
- A degree in medicine
- Proven skills and/or an interest in performing literature searches, analyzing and writing/presenting scientific data
- Preferably, experience from the medical device or pharmaceutical industry
- Preferably, knowledge of regulatory requirements for medical devices
- Fluent in English and Danish
Medical Affairs and Regulatory Affairs operate in a global environment which requires excellent communication skills and a flair for collaboration at all levels. You have an eye for detail while still the ability to juggle multiple tasks and projects across the organization in a thorough and systematic way. You work independently within your own areas of responsibility and have proven ability to exercise sound judgement in independent decision-making. Importantly, we expect you to be an excellent team player with a positive and committed approach to your tasks. Finally, you wish to work in a global, yet local environment.
We are looking for a positive and vigorous person who is ready for new challenges and to assist in expanding the Medical Affairs function at Cook Medical in Denmark.
Cook Medical’s company culture is based on a set of strong common values. Responsible, competent, and professional employees are our most important resource.
We have a flat organizational structure and focus on open dialogue. Qualities such as determination, loyalty, and humor are highly appreciated. The staff of Cook Medical helps uphold the company’s philosophy of developing innovative medical solutions to raise the quality of patient treatment worldwide - we make a difference every day.
Cook Medical offers a well-organized internal training course which is taken by all new staff to enable them to quickly gain a thorough knowledge of the company.
In addition to a salary package with a pension, we offer flex time, a bonus system, health insurance, and free use of the company’s own gym.
Contact Karin Nielsen, Manager, Regulatory Affairs by phone: +45 56 86 88 86 or e-mail: Karin.Nielsen@cookmedical.com.
Applications must be submitted no later than November 10, 2019.