Medical Advisor in Medical and Regulatory Affairs

Medical Advisor in Medical and Regulatory Affairs

Cook Medical

Bjæverskov, Denmark

Overview

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.

As 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. The Medical Advisors work closely together with colleagues internally from Product Development, Clinical Affairs, Quality Assurance, Quality Engineering, and Marketing as well as with colleagues from other Cook Sites and the global Medical Affairs team.

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

Responsibilities

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, Quality Engineering, and Quality Assurance to assess the relative risks and benefits of William Cook Europe devices throughout product 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 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;
  • Contribute to and align with the Cook Global Medical Affairs function.

Qualifications

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 collaboration 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 environment.

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Cook Medical     Denmark     Clinical Research     Medical     Medical Advisor     Medical Devices     Physician     Regulatory Affairs     3 - 4 Years Experience    

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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