Arbejde Experienced RA Specialist-RAD001200 Hovedstaden RADIOMETER MEDICAL ApS - jobtilbud

GÆLDER
stillingsbetegnelse: Experienced RA Specialist-RAD001200

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 IVD/Medical Devices – Blood Gas business area – Cross-functional projects If you possess profound knowledge within the IVD/Medical Device legislation, you maybe our new RA specialist for Radiometer’s Blood Gas area. Top focus will be on Blood Gas clearance for products, on participation in various R&D projects, and on continuation of the ongoing regulatory processes within the Blood Gas area and in the RA department. The Regulatory Affairs team in Radiometer consists of 12 competent and dedicated employees. 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 Your responsibilities and tasks will include: •Project manager/participant within R&D projects covering Regulatory issues. •Compiling of dossiers to obtain approvals, especially in EU, US, Japan and China. •Legislation monitoring and being able to translate this and implement this in Radiometer. •Maintain Market approvals and current documents within responsibility area. •Participate in process improvements and creation of SOPs in the RA area. Successful execution of these tasks depends on cross-functional cooperation with QA,R&D, Production, Sales and Marketing and other departments. 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 or Engineering, preferably with experience from a similar job. •Profound experience with the medical device legislation (IVD, MDD) in EU, US, China and Japan. Knowledge of other markets would be an asset. •Proven track record of compiling regulatory files and achieving approvals. •Experience working in development projects and having cross-functional interaction. •Experience working with different cultures. •Experience interacting and negotiating with regulatory authorities. •Fluent English required, both spoken and written. •Used to working with MS Office and databases. You must be passionate and committed about what you do, as well as: •Excellent analytical skills. •Positive and open-minded, adding energy to the team by taking responsibility and being engaged and committed about what you do. •Able to communicate effectively and act proactively. •Focusing on targets and results. •Able to work 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 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 adifference in a company whose products can truly impact other people's lives.We offe

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

GÆLDER

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