stillingsbetegnelse:
Regulatory Affairs Director for Durable Devices and Digital Health

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Join a fast-changing environment where engaged people do their best every day to obtain and maintain market authorisations worldwide for all Novo Nordisk medicine 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 (RA) a truly interesting place to work – but also quite challenging. Are you up for the challenge? 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 25 colleagues, divided in two departments. You will be heading up the department for durable medical devices, needles and digital health with 9 engaged employees placed in Soeborg. We have a wide range of stakeholders within Device R&D, QA, Medical & Science, Marketing, Product Supply 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 position 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 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. Going forward digital health solutions will also be part of the responsibility of this department. 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 optimising 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 a proven record of extensive global regulatory understanding and experience, successful liaison with certified bodies and regulatory authorities, solid medical device understanding, as well as cross-organisational experience in global device development. Experience within digital health solutions is an advantage. 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, and you have a sense of humour. RA 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. Working at Novo Nordisk At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment. Contact For further information, please contact Lene Garde Sommer at +45 3075 9762. Deadline 5 June 2016.

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