Senior Regulatory Professional RA Devices

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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 Devices is part of the Regulatory Affairs CMC & Device Area. In RA Devices focus is on medical devices, drug/device combination products and our primary responsibility is to provide regulatory input to device projects and products globally. This is achieved by developing and implementing regulatory strategies based on current legislation and regulations. We are also responsible for updating or maintaining regulatory files within the defined area of responsibility, including evaluation of the regulatory implications of changes and necessary actions. You will be cooperating closely with a wide range of stakeholders from e.g. Product Supply, Device R&D, QA, Medical & Science and Marketing.

The job

As Senior Regulatory Affairs Professional you will be responsible of compiling and submitting files for Novo Nordisk drug/device combination projects and products according to the relevant regulatory strategy in collaboration with stakeholders across Novo Nordisk. You will facilitate the approval process by identifying device key issues, interaction with the regulatory authorities and ensuring timely and high-quality answers to authority questions.

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 projects involving highly skilled people – all experts within their field.

As the area is moving into handling and managing more and more complex projects involving many stakeholders, this position requires independent drive, proactive and innovative mind-set as well as talent for project management.

Qualifications
You hold a master’s degree in Science, Engineering, Pharmacy or other relevant education and you have minimum 5 years of relevant experience working with regulations of medical devices. 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 are able to bring valuable input and set the strategic direction for the project(s). Finally, you can communicate complex 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 at +45 3077 7350 or Karen Kristiansen at +45 3075 5796

Deadline
Please apply for the position no later than 9. September 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.


Information og data

Denne ledige stilling har jobtypen "Kemiker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i Søborg.

Jobbet er oprettet på vores service den 17.8.2019, men kan have været deaktiveret og genaktiveret igen.

Rapportér
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Kemiker
  • Søborg
Rapportér

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