stillingsbetegnelse: Department Manager, Regulatory Affairs Devices

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. At Novo Nordisk, we share a passion for changing patients´ lives, and we are always looking for talented individuals who want to join us in this effort. If you are motivated by the opportunity to combine your leadership skills, scientific device understanding, and regulatory insight, you may be the person we seek. About the department Novo Nordisk is one of the world’s most successful pharmaceutical companies and with a strong growth potential. You will join the Regulatory Affairs Device function consisting of 24 colleagues, divided in two departments. You will be heading up the department for prefilled medical devices with 9 engaged employees placed in Soeborg. We have a wide range of stakeholders within Device R&D, QA, Medical & Science, Marketing, Product Supply, Regulatory Affairs as well as our affiliates. Our main activity is to obtain and maintain marketing approval for our devices worldwide. This is achieved by developing and implementing regulatory strategies based on current legislation and regulations. The job As Department Manager your primary focus is to lead the people and make sure the department can support the development, registration and maintenance of our prefilled medical devices worldwide. You will follow device development projects from the early phases into maintenance, providing input and translating complex regulatory issues into valuable information to the products, to ensure the best regulatory strategy during development. Our organisation is dynamic, with change management being an integral part of our everyday life. The job puts high demands on your leadership skills in terms of performance management and your ability to develop your direct reports on the basis of individual and business needs. You report to the Vice President for RA Devices, and you are a member of the Area’s line management team that is responsible for organisational and staff matters, including the optimising of resources across the Area. In addition, there is a constant focus on optimizing our working processes, and you will be involved in cross functional projects and improvement initiatives within and outside the RA organisation, as well as collaboration with all the stakeholders. Qualifications You hold a university degree in science and you have a proven track-record of extensive global regulatory understanding and experience, successful liaison with notified bodies and regulatory authorities, solid medical device understanding, as well as cross-organisational experience in global device development. You have documented people management experience: you set direction, lead and motivate your staff to work for joint objectives. As a person you are well organised and have solid problem-solving capabilities, just as you show a winning attitude and never lose your strategic focus. You can keep your spirits high even when under pressure, and as a skilled communicator you can cooperate at any organisational level. Finally, you are comfortable using your fluent written and spoken English on a daily basis. Regulatory Affairs is an organisation with many international employees and we welcome non-local applicants. We have great experience helping people move to Denmark and will support relocation 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 Lene Garde Sommer, on +45 3079 9762. Deadline 1 March 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark