Senior Regulatory Professional in 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
The RA Devices department is part of the Regulatory Affairs CMC & Device organisation and consist of 16 engaged and ambitious employees. Our key responsibilities are to ensure regulatory compliance in the development projects of medical devices and drug/device combination products and to provide regulatory input to our 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, Affiliates and Marketing.
The job
As Senior Regulatory Professional you will be working in one or several of the development projects in Device R&D where you will be the person representing regulatory from the device perspective. In that role you will be responsible for providing regulatory input to the strategy, review submission documentation, clinical trial documentation and preparing material for interaction with health authorities. Furthermore, 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.
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.
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.
Qualifications
You hold a master’s degree in Science, Engineering, Pharmacy or other relevant education and you have minimum 6 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 Charlotte Bennrup + 45 3075 8404
Deadline
21 February 2020. Applications will be evaluated continuously when received and candidates may be called or interview before the deadline.
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 "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 27.1.2020, 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.
- Afdelingsleder
- Søborg
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