stillingsbetegnelse: RA specialist-MED000773

jobbeskrivelse:
About Us We save lives for a living The difference between life and death can be just a few minutes. Radiometer’s diagnostic equipment is of crucial importance to doctors all over the world in their effort to diagnose critically ill patients quickly and accurately. From biotech and software specialists to financial controllers and engineers, all 2700 colleagues are committed and dedicated in their effort to make an impact on the life of others with our high-quality solutions. Radiometer’s leading position in the market has been secured over the last 80 years. Together we continue to raise the bar in acute care and constantly develop in new areas. Radiometer has an annual turnover of more than $ 684 million worldwide and is owned by US-based Danaher Corporation. Description Are you familiar with In Vitro Diagnostics and Medical Device legislation and international registration? If you are interested in starting out with 18 months of employment, 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 just launched a 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 person to fill a position as RA specialist for international registration. This is a temporary position, which may be prolonged. Your responsibility area would be to ensure market approvals for Radiometer’s product areas, such as Immunoassays, Transcutaneous monitors, Samplers, IT Solutions, and the Blood Gas products. Together with our local sales companies, we are responsible for preparing and compiling regulatory dossiers to ensure their content is in accordance with internal and external guidelines, and maintaining current market approvals and documentation. 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. •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. Qualifications "Constructive Diversity" is one of our core values, and we believe that human diversity creates a dynamic and creative environment. Therefore, we encourage diversity through our recruitment process. However, we believe that the following formal qualifications will improve your chances of success: •Master Degree in Science, Engineering, Pharmacy, Biology, Biochemistry or similar. •The preferred candidate has: ?experience with the medical device legislation (IVD, MDD) on different markets worldwide ?a proven track record of compiling regulatory files and achieving approvals ?experience with work relations in different cultures •Strong communication skills. •Fluency in English, both written and spoken. Danish would be an asset, as would other languages such as Spanish or French. •Experienced MS Office (Excel, PowerPoint, Word, and Outlook) user. Familiar working in databases and with Adobe Pro. You must be passionate and committed about what you do, as well as be: •Good analytical skills. •Positive and open-minded, adding energy to the team by taking responsibility and being proactive and bringing a can-do attitude. •Focused on targets and results, and working well independently as well as in teams. •Able to handle and prioritize many projects at the same time. We offer you A unique opportunity to work in the field of medical technologies, where knowledge sharing and profe

Arbejdsgiver Navn: RADIOMETER MEDICAL ApS

Arbejdsgiver telefonnummer: 38272829

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark