Arbejde Regulatory Professional Hovedstaden Novo Nordisk A/S - jobtilbud

GÆLDER
stillingsbetegnelse: Regulatory Professional

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Our growth is your opportunity Being part of Novo Nordisk Research & Development means working at one of the world's largest and most successful biopharmaceutical companies. Our R&D organisation is vital to Novo Nordisk's continued growth and we always welcome talented people who would like to grow with us. Do you have a solid regulatory toolbox within medical devices? Would you like to proactively ensure that development projects meet regulatory requirements, collaborate with your regulatory colleagues worldwide and help find the regulatory path for devices and thus enable our “fast to market” mission? About the department You will join the Regulatory Affairs Device group which consists of 23 colleagues, divided into two departments. Here, you will join the RA Prefilled Devices department. As globally responsible for supporting the registration of medical devices worldwide, we continuously strive to stay 100% up-to-date with global regulatory requirements regarding regulations. As new Regulatory Affairs Professional, you have solid RA or QA experience with medical devices or drug-device combinations. The job The position is two-fold. On one hand, you will follow device development projects from the early phases, providing input and translating complex regulatory issues into valuable information to the project, to ensure the best regulatory strategy. Further, your tasks include reviewing and approving reports, documents etc. to be used in the regulatory files. On the other hand, it will be your responsibility to coordinate and plan regulatory submission and approvals with our drug regulatory departments as well as support the affiliates with information going beyond the standard regulatory files. You will have the unique opportunity to establish a global network working with our affiliates and to enhance your knowledge by participating in a range of development projects manned with highly skilled people – all experts within their field. Qualifications You hold a Master’s degree in Science, Engineering or Pharmacy combined with experience within regulations of medical devices and knowledge of international regulatory laws and standards – particularly within the EU, US, Japan as well as other important business areas. It is imperative that you are self-driven and able to make the right regulatory decisions – and thus set the regulatory agenda. With proactive approach you are able to bring valuable input and support to the projects. Finally, you are able to communicate complex regulatory issues to a large mix of stakeholders from R&D to production and marketing. At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Contact For further information please contact Kirsten Nielsen Tallerup at +45 3079 6255. Deadline 23 November 2014.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

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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