stillingsbetegnelse: Regulatory Project Manager within 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 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 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 placed in Søborg just outside Copenhagen. 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 Novo Nordisk has embarked on an exciting journey in our mission to improve the life of people suffering from diabetes by developing products within Digital Health. As a regulatory project manager you will be the key regulatory contributor to the development and approval of mobile applications by providing various deliverables throughout the product development and submission processes. You will work closely together with our external partner IBM Watson Health and our internal project team developing innovative new products within this new and exciting sector. We need a person who understands the regulatory requirements for a Digital Health application both for development and launch. You will be expected to provide leadership in the strategy and implementation of regulatory concepts within cross-functional teams and continue to expand knowledge base of laws, regulations and guidelines on an on-going basis – to begin with primarily in the US and EU, but in the longer run also globally. You will be working in an international set-up with project members based in the US and in Denmark. Therefore, you must have an international mind-set and a high degree of flexibility to accommodate different needs and priorities as well as being able to work across time zones. Qualifications You hold a master degree in engineering, pharmaceutical science or similar and you have at least 7+ years of regulatory experience of device development including 510(k), PMA and IDE submissions including digital health care experience. You have a solid understanding of software or mobile app development that enables you to provide qualified regulatory advice and guidance to the development engineers. You master all the classical project manager disciplines such as identifying scope, creating project plans as well as managing, monitoring and controlling multiple external and internal stakeholders throughout the project lifecycle. You have demonstrated a high level of energy, resilience and physical and mental capacity. You are out-going with an effortless ability to create relations and contacts at all levels in organisational life. You work effectively in a team environment and with global team members. You will be working independently but in strong alignment with the regulatory organisation and project members. You will be communicating with stakeholders at all levels and you handle this level of communication smoothly. In addition, you have strong analytical skills and you are eager to find solutions and answers - also in difficult situations and in unexplored territory. Finding new ways and solutions within the regulatory framework is natural to you enabling you to come up with strong strategies ensuring a smooth approval of our products. Regulatory Affairs is an organisation with many international employees and we welcome non-local applicants. We have

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