Department Manager Regulatory Affairs 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. This makes Regulatory Affairs a truly interesting place to work – but also quite challenging. Are you up for this challenge?
About the department
You will join RA Devices & Digital Health where 21 colleagues are working in two departments. RA Devices consist of 15 people and our focus is both drug/device combination products and medical devices. 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 maintaining regulatory files, including evaluation of the regulatory implications of changes and necessary actions in close collaboration with our colleagues in Bangalore, India. As leader of the department 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 Department Manager you will lead the people and make sure the department can support the development and submissions of drug/device combination products and medical devices worldwide. You will follow the development projects from early phases into maintenance providing input and communicating regulatory requirements to stakeholders to ensure the best regulatory strategy during development.
Our organisation is dynamic with change management being an integrated part of leading the people.
In addition, there is a focus on optimising work processes both in relation to implementation of new regulations but also in cooperation with our colleagues Bangalore, India. You will also be involved in cross functional projects with our stakeholders and get a unique opportunity to establish a global network working with our affiliates.
Qualifications
You hold a master’s degree in Science, Engineering, Pharmacy or other relevant education and have extensive experience in working with Medical Devices, including knowledge of relevant legislation. You have demonstrated your ability to lead collaborative teams and have experience with setting directions and motivating people to be ambitious in their work and interaction with stakeholders.
As a person you have a proactive mindset – you take the lead on overcoming challenges and show your team the way forward. You demonstrate a sound business understanding when you develop regulatory strategies. You believe in empowering people around you, offering them constructive feedback and guidance to improve their performance. You are well-organised and have a good strategic focus. Your can keep your spirits high even under pressure and as a skilled communicator you can cooperate at any organisational level.
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 Senior Director, RA Devices & Digital Health, Pernille Skindhøj at +45 3077 7350.
Deadline
Please apply for the position no later than August, 12th 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 "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 23.7.2019, 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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