Regulatory Affairs Professional; RA Digital Health
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Søborg
- Regulatory
- Søborg
Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicine and devices approved globally.
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 that challenge?
About the department
RA Digital Health (DH) is part of the RA Device & DH within RA CMC & Device. In RA DH, our primary responsibilities are to provide regulatory input and obtain regulatory approvals for our digital health projects. This is achieved by developing and implementing regulatory strategies based on current legislation and regulations and negotiating with authorities to ensure minimum time to market.
As part of RA DH you cooperate closely with a wide range of stakeholders from Device R&D, IT, Marketing, Medical & Science and Affiliates. To ensure full integration with the Digital Health Project teams RA DH is co-located in the project teams.
The job
You will be involved with the Digital Health project teams from the start. In cooperation with the RA DH team you will be responsible for, interacting with health authorities and submitting regulatory files to ensure product approval. Your regulatory expertise is needed to determine the regulatory strategy, establish and maintain dialogue with authorities and support the projects as well as the affiliates.
You will get a unique opportunity to establish a global network working with our affiliates and to enhance your knowledge by participating in a wide range of innovative digital health projects involving highly skilled people.
Qualifications
You hold a master’s degree in computer science, engineering or other relevant education and you have minimum 2 years of relevant experience working with regulations of medical devices, preferably containing software. Knowledge of international legislation and standards, experience from the pharmaceutical industry as well as project management will be an advantage.
It is imperative that you are self-driven, have a strategic mind-set and able to make the right regulatory decisions – and thus drive the regulatory agenda. With a proactive and innovative approach, you can bring valuable input and support setting the strategic direction for the project(s). Finally, you can communicate regulatory topics to many different stakeholders from R&D to production and marketing.
You are fluent in written and spoken English, have strong communication skills and you bring a can-do attitude.
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 Pernille Skindhøj: +45 3077 7350 or Stewart Polley at +45 3079 3740.
Deadline
27. April 2020.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 6.4.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Søborg
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