Specialist, Medical Communication, Regulatory Affairs
To ensure continued clinical expertise as an integrated part of the product lifecycle, we are looking for two new colleagues with a clinical or scientific background.
As a medical communication specialist in Regulatory Affairs you will join a team of 30 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 provide support to the Vascular and MedSurg business divisions within the specialty areas Aortic Therapies, Venous Therapies, Peripheral Artery Disease Therapies, Embolic Therapies and Critical Care. You can learn more about our business divisions on www.cookmedical.eu.
Your main responsibilities as Medical Communication Specialist will be:
- Preparation and maintenance of Clinical Evidence Reports
- Provide input to Post Market Surveillance, including post-market literature search and clinical advice for marketed devices
- Participate in product development projects, providing the clinical input e.g. clinical design requirements, risk analysis, instructions for use and clinical trial strategy
- Collaborate with internal and external regulatory colleagues on writing clinical documentation for submissions worldwide (e.g. Europe, US, Japan, China, Australia and clinical study documentation)
- Prepare literature reviews in connection with post market vigilance.
- Perform 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
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.
Cook Medical has a healthy company culture with a strong common set of values. Responsible, competent and professional staff is 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 to 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 thorough knowledge of the company.
In addition to a salary package with pension, we offer flex time, a bonus system, health insurance, as well as free use of the company’s own gym.
For further information about the job, please feel free to contact Mie Dyrholm, Manager Venous, PAD, Embolic Therapies and Critical Care, Regulatory Affairs, Regulatory Affairs by phone: +45 56 86 84 92 or e-mail: mie.dyrholm@CookMedical.com orKarin Nielsen, Manager Aortic Therapies, Regulatory Affairs by phone: +45 56 86 88 86 or e-mail:Karin.Nielsen@cookmedical.com