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Specialist, Medical Communication, Regulatory Affairs

To ensure continued clinical expertise as an integrated part of the product lifecycle, we are looking for a new colleague with a clinical or scientific background.

As a medical communication specialist in Regulatory Affairs, you will join a team of 29 dedicated colleagues working with regulatory activities worldwide. We work closely together with other colleagues in the fields of development, clinical research, manufacturing, quality and marketing as well as with colleagues of our main office in the US.

In Regulatory Affairs, we primarily provide support to the business units Aortic Intervention, Critical Care, Interventional Radiology, and Peripheral Intervention. You can learn more about our business units at www.cookmedical.eu.

Responsibilities

Your main responsibility as Medical Communication Specialist will be:

  • Preparation and maintenance of Clinical Evidence Reports.
  • Providing input to Post Market Surveillance, including post-market literature search and clinical advice for marketed devices
  • Participating in product development projects, providing the clinical input e.g. clinical design requirements, risk analysis, instructions for use and clinical trial strategy.
  • Collaborating with internal and external regulatory colleagues on writing clinical documentation for submissions worldwide (e.g. Europe, US, Japan, China, Australia and clinical study documentation).
  • Preparing clinical assessments in connection with post market vigilance.
  • Performing clinical review of marketing material (e.g. instructions for use, brochures, and presentations).
  • Gaining and maintaining product expertise and a solid understanding of internal procedures and clinical regulatory requirements.

Qualifications

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

  • A clinical education or other relevant scientific educational background e.g., a degree in Life Science, Pharmaceutical Science or other relevant background.
  • Proven skills of analyzing and presenting scientific data and literature searches.
  • Preferable experience from working in the medical device or pharmaceutical industry.
  • Preferable knowledge and understanding of regulatory requirements for medical devices.
  • Excellent verbal and written communication skills in English and Danish.

Regulatory Affairs operates in a global environment which requires excellent communication skills and a flair for collaborating at all levels. As a colleague, you have an eye for details while still the ability to juggle multiple tasks and projects across the organization in a thorough and systematic way. It is obvious that you work independently within your own areas of responsibility. 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 and the wish for working in a global, yet local environment.

We offer

Cook Medical's company culture is based on a set of strong common values and 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 humour 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.

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

Further information

Please contact Mie Dyrholm, Team Lead PI/IR/CC, Regulatory Affairs by phone: +45 56 86 84 92 or e-mail: mie.dyrholm@cookmedical.com

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Arbejdssted

Bjæverskov

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