Cook Medical

Cook Medical,


Medical Advisor in Medical and Regulatory Affairs


Cook Medical

Sandet 6
Praktisk information
Speciale uafhængig
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Cook Medical is looking for

To ensure continued clinical expertise as an integrated part of the lifecycle of our portfolio of medical devices, we are looking for a medically qualified colleague.


In this newly created position as Medical Advisor jointly assigned to Medical and Regulatory Affairs, you will join our team of 30 dedicated colleagues in Denmark working with clinical and regulatory activities worldwide. We work closely together with other colleagues in the fields of Product Development, Clinical Research, Manufacturing, Quality Assurance, Quality Engineering, and Marketing as well as with colleagues of our Headquarters in the US and the global Medical Affairs team.


This position will primarily provide support to the Vascular Division of Cook Medical, including Aortic Intervention, Critical Care, Interventional Radiology and Peripheral Intervention.

You can learn more about our Medical Divisions at


Job profile

Your main responsibilities as a Medical Advisor will be:


  • Building and maintaining a working knowledge of William Cook Europe product lines, both new and existing products, and the clinical procedures for which they are used. Have a clinical understanding of the risks, benefits, patient selection and treatment options for the appropriate disease groups.

  • Working closely with Regulatory Affairs, Medical Communication, and Quality Assurance to assess the relative risks and benefits of William Cook Europe devices throughout their life cycle.

  • Assisting in identifying clinical evidence gaps related to William Cook Europe technologies, contributing to clinical trial design where relevant, and contributing to the review of clinical evaluation reports.

  • 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, as well as press releases.

  • Providing clinical experience and support to Regulatory Affairs, Quality Assurance, Engineering, Clinical Affairs, Marketing / Division, Reimbursement and other internal groups and processes as needed.

  • Contribute to and align with the Cook Global Medical Affairs function.



Employee profile

As a Medical Advisor, you are expected to have the following qualifications:


  • A medical degree in medicine

  • Proven skills in performing literature searches, analyzing and writing/presenting scientific data

  • Experience in the medical device or pharmaceutical industry (preferable)

  • Knowledge of regulatory requirements for medical devices (preferable)

  • Fluent in English and Danish



Regulatory and Medical Affairs operate in a global environment which requires excellent communication skills and a flair for collaborating at all levels. You have an eye for detail while still the ability to juggle multiple tasks and projects across the organisation in a thorough and systematic way. You work independently within your own areas of responsibility. 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. You have excellent communication skills at all levels. Finally, you wish to work in a global, yet local invironment.


We are looking for a positive and vigorous person who is ready for new challenges and ready to build up a new position at Cook Medical in Denmark.


We offer

Cook Medicals 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 companys philosophy of developing innovative medical solutions to raise the quality of patient treatment worldwide - we make a difference every day.


In addition to a salary package with pension, we offer flex time, a bonus system, health insurance, and free use of the companys own gym.


Further information

Contact Karin Nielsen, Manager, Regulatory Affairs by phone: +45 56 86 88 86 or e-mail:


Written application

Please upload your application, references and CV to the Cook Careers Portal at


Alternatively, send your application with references and CV by e-mail to Birte Nielsen, Human Resources Generalist, Recruitment, at


Applications must be submitted no later than March 18, 2018.


Company profile

Cook Medical is a leader in researching, developing and manufacturing medical technologies that improve the quality of life for patients around the world. To provide our customers with the best possible support, we have two divisions, each specializing in a range of particular segments of medicine. Products are manufactured on three continents and are distributed to 135 countries. We currently employ around 850 people in Denmark, William Cook Europe, Sandet 6, 4632 Bjaeverskov.

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nr. 14/2016