Empleo en Dinamarca (HOVEDSTADEN) de Biólogos, botánicos, zoólogos
Regulatory Affairs Specialist - Temporary
Clasificación del trabajo:Profesionales científicos e intelectuales : Profesionales de las ciencias y de la ingeniería : Profesionales en ciencias biológicas : Biólogos, botánicos, zoólogos y afines. Arbejde, der forudsætter viden på højeste niveau inden for pågældende område : Arbejde inden for naturvidenskab og ingeniørvirksomhed : Arbejde inden for biovidenskab : Arbejde inden for biologi, botanik, zoologi og beslægtede områder.
Descripción de la oferta de trabajo:
About Us At Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions – decisions that in the end help save lives. On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses. Want to know more about our mission and vision? Click on the link: Link of YouTube video Our people At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3200 colleagues are committed and dedicated to help realize life’s potential. If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you. Description Are you familiar with In Vitro Diagnostics, Medical Device legislation, labelling and international registration? If an 18-month position suits you, this could be the right opportunity for you! In Radiometer’s RA/QA department we are Partnering for Impact to be a competitive advantage for reliable, fast and easy patient diagnoses. We have launched our 3-year strategy, and a lot of interesting tasks and projects lie ahead of us. In the area of Medical Devices and In Vitro diagnostics, the legislation is increasing worldwide. Therefore, we are seeking a positive and open-minded person to fill a position as RA specialist for our International Registration team consisting of 8 dedicated people. The position is a 18-month temporary position, which may be prolonged. Your area of responsibility will be to ensure market approvals for Radiometer’s different product areas such as Immunoassays, Transcutaneous Monitors, Samplers, IT Solutions, and the Blood Gas products – this requires special knowledge within In Vitro Diagnostics- and Medical Device legislation. Furthermore, you will be part of the labelling process from a regulatory perspective. Together with our local sales companies, we are responsible for preparing and compiling regulatory dossiers to ensure that their content is in accordance with internal and external guidelines. In addition to this, we maintain current market approvals and documentation. You will work together with both internal and external stakeholders within the labelling area. The job To become successful, you must cooperate cross-functionally with QA, R&D, Production, Sales, Marketing, and other departments. Your responsibilities and tasks will include: •International registration by compiling of dossiers to obtain approvals worldwide. •Legislation monitoring and being able to translate and implement this in Radiometer. •Maintain market approvals and current documents within your responsibility area. •Support to labelling process and projects. •Participate in process improvements and creation of SOPs in the RA area. The position does not require a lot of travelling, but some days during the year must be expected. Application deadline is August 20 Interviews will be held as soon as relevant candidates apply. Start the application process as soon as possible by pressing "Apply Online" and follow the guidelines on our corporate career site. Please attach your CV and other relevant documents, and bring diplomas if invited for an interview. We look forward to receiving your application. For further information, please contact Regulatory Affairs Manager, Mette Skytte Harpsøe at tel. +45 3031 9427. Qualifications "Constructive Diversity" is one of our core values, and we believe that human diversity creates a
Servicio de empleo de origen:AMS, Servicios Públicos de Empleo, Dinamarca.