stillingsbetegnelse: RA Specialist - Vigilance-RAD001201

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 – Cross-functional projects – SOPs and documentation Do you want to work with vigilance, cross-functional projects, and with RA projects focusing on vigilance? Then you might be the candidate we are looking for! The job requires knowledge within the IVD/Medical Device legislation, preferably with experience with vigilance reporting. 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 ensuring compliance in the vigilance area as well as preparing and compiling regulatory dossiers and maintain market approvals. The job Your responsibilities and tasks will include: •Ensuring timely reporting of adverse events and field actions worldwide. •Legislation monitoring, and being able to translate and implement this in Radiometer. •Participate in process improvements and creation of SOPs in the RA area. •Maintain documentation in RA. 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, e.g. in Pharmacy, Biology or Engineering. •Experience with the medical device and/or IVD legislation. •Experience working with vigilance and having cross-functional interaction. •Experience negotiating with regulatory authorities. •Experience with effective national and international communication. •Fluent English required, both spoken and written. •Used to working with MS Office and databases. You must be passionate and committed aboutwhat you do, as well as: •Analytical and are able to digest complex problems. •Positive and open-minded, adding energy to our team by taking responsibility. •Able to communicate effectively and act proactively. •Focusing on targets and results. •Able to work independently as well as in teams. 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 contact Director, Regulatory Affairs, Gitte Juul Friis at mobile phone +45 2169 3280. Interviews will be held as relevant candidates apply ...so there is no deadline and you can apply right away. Start the application process by pressing "Apply Online" and follow the guidelines on our corporate career site. Attach your CV and other relevant documents. We are looking forward to receiving your application. Dana

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