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stillingsbetegnelse: Regulatory Specialist RA Device, Digital Health

jobbeskrivelse:

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 Device, Digital Health is part of the Regulatory Affairs CMC & Device Area.

In RA Devices, Digital Health 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 Device, Digital Health you cooperate closely with a wide range of stakeholders from e.g. Device R&D, IT, Marketing, Medical & Science and Affiliates. To ensure full integration with the Digital Health Project teams RA Device, Digital Health 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 Device, Digital Health 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 – all experts within their field. Most importantly, you will have the possibility to influence your role according to your specialization.

 

Qualifications
You hold a master’s degree in Science – e.g. computer science, engineering or other relevant education and you have minimum 10 years of relevant experience.

Knowledge of international regulations, including radio regulations, quality management systems, standards and experience with 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 in a fast-moving environment – and thus drive the regulatory agenda. With a proactive and innovative approach, you bring valuable input and set the strategic direction for the project(s). Finally, you can communicate complex regulatory topics to many different stakeholders. 

You speak and write English at a mothertongue level, 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 either Pernille Skindhøj at +45 3077 7350 or  Stewart Polley at +45 3079 3740. 

Deadline
Applications will be processed continuously so do not hesitate to apply for this exciting opportunity. Please apply for the position no later than 8. May 2019.

 

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.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2423

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: Novo Nordisk A/S

source: DK-STAR