stillingsbetegnelse: Experienced RA Specialist-MED000271

jobbeskrivelse:
Danaher Company Description Radiometer - Make an impact on life. 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 2500 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 50 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 DKK 3 billion and is owned by US-based Danaher Corporation. Description Are you an experienced Regulatory Affairs professional? Are you used to working towards regulators and authorities? As RA Specialist for Radiometer’s various product areas – such as the Immuno Assays and the Blood Gas area – you must possess profound knowledge of the legislation within In Vitro Diagnostics and Medical Device. Your primary responsibilities will be to achieve approvals for products, to participate in R&D projects, and to continue the ongoing regulatory processes in the area. Together with our local sales companies and Danaher's QA/RA organization, we are responsible for preparing and compiling regulatory dossiers to ensure that their content is in accordance with internal and external guidelines and maintain current market approvals and documentation. The job To become successful, you must cooperate cross-functionally with QA, R&D, Production, Sales and Marketing and other departments. Your responsibilities and tasks will include: •Project management/participation within R&D projects covering regulatory issues. •Compiling of dossiers to obtain approvals especially in EU, US, Japan and China. •Legislation monitoring, translating this and implementing in Radiometer. •Maintaining market approvals and current documents within your responsibility area. •Participating in process improvements and creation of SOPs in the RA area. 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: •A Master degree in Pharmacy, Biology, Biochemistry, Engineering, or similar. •Experience from a similar job is required – especially with the medical device legislation (IVD, MDD) in EU, US, and Japan. Experience with other markets would be an asset. •Proven track record of compiling regulatory files and achieving approvals. •Used to working in development projects, having cross-functional interaction. •Experience with interaction and negotiations with regulatory authorities. •Fluent in English, both written and spoken. You must be passionate and committed about what you do, as well as: •Excellent analytical skills. •A good communicator with a positive, open-minded approach, adding energy to the team by taking responsibility. •Pro-active with focus on targets and results, and with the ability to handle and prioritize many projects simultaneously. •Work well independently as well as in teams, and with different cultures. We offer you A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Denmark and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility', opportunities for training and career development, and a wide range of staff benefits. For further information, please contac

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