stillingsbetegnelse: RA Associate

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicine and devices approved across the globe. Our people have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting place to work – but also quite challenging. About the department You will join the Regulatory Affairs Device function consisting of 25 colleagues, divided in two departments. The position is based in the department for re-useable medical devices and needles with 8 engaged employees placed in Soeborg. We have a wide range of stakeholders within development, QA, medical, marketing, product supply as well as Regulatory Affairs in our affiliates. Our main activities are to develop strategies based on current laws and regulations regarding medical devices and to get the devices marketed worldwide. The job We are looking for a person who enjoys structure, promptness and a dynamic environment. You will collaborate with colleagues from Novo Nordisk in Denmark as well as with affiliates. Part of your everyday work will include quality check of documents for regulatory submissions, and compiling and archiving of electronic documents into our global document management system. We work with several different submissions/projects and thus you need to be able to joggle several tasks at the same time. You will assist and work together with the academics in the changes being implemented during life Cycle management for the devices. In Regulatory Affairs, you’ll work in a frequently changing environment where tasks and priorities may change from one day to the other. Tight deadlines, cross-departmental collaboration, together with challenges of international communication will be part of your workday In addition there is a focus on optimizing our working processes, and several improvements activities have recently been identified in the area. You will be part of this process where we will draw on your previous experience and competencies. The job requires working independently and good coordination and planning skills, accountability and the ability to work under tight deadlines. Qualifications You have a relevant educational background, as minimum a bachelor´s degree in science, business administration or English. Administrative experience working with regulatory affairs and/or medical device development is preferred. You have experience with professional use of IT systems such as electronic document management and are proficient in the MS Office. As a person you thrive in busy environments and you bring a can-do spirit and a healthy common sense and a sense of humour to your work – even when the pressure is on. You’re a strong team player, but you also enjoy working independently. Furthermore you are well organised and a good planner. You are a skilled communicator, who is able to collaborate with a lot of stakeholders and comfortable using your fluent written and spoken English on a daily basis. 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 Mette-Marie T. Nøigaard on +45 3079 4462. Deadline 11 August 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Arbejde inden for samfundsøkonomi

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark