- Daily leadership tasks for the people in your team and set direction
- Supervising and developing the team to ensure that we provide best in class regulatory strategies for the Digital Health and IVD activities
- Being part of an organisation that works as a strategic business partner across various parts of a product's life cycle
- MSc or PhD in a scientific, engineering, or other relevant field
- Experience within Regulatory Affairs (directly or indirectly) with, at least, 6 years of track record from the pharma industry, including leadership positions
- In-depth knowledge of MDR and current Regulatory Standards is desirable
- Proficiency in handling regulatory submissions of devices, SaMD (Software as a Medical Device) and/or connected devices globally
- Professional proficiency in English
Associate Director for RA, Digital Health - Søborg, Danmark - Novo Nordisk A/S
Beskrivelse
Do you aspire to accelerate your leadership career within a global pharmaceutical company built on life-changing innovations? Does leading a department of incredibly talented and engaged colleagues from diverse cultural and professional backgrounds inspire you?
In Novo Nordisk, we are embarking on a journey to reach 5D ambitions moving towards being a company integrating Drug, Device, Diagnostics, Digital and Data. Digital Health and IVD (In Vitro Diagnostic) activities are becoming increasingly important as our integrated project development strategies include these elements - do you want to be part of driving it?
If yes, you could be the person we are looking for as Associate Director in Regulatory Affairs Digital Health & IVD.
The position
We are looking for a leadership colleague that can set direction and have a strong drive to succeed together as a team to join RA Digital Health & IVD.
Your main responsibilities as Associate Director will be focused on:
You have exciting opportunities in both our department and across the company and you are expected to carry on this mindset when developing yourself as well as your team.
You can either work from our office in Søborg, Denmark or in Gatwick, UK.
Qualifications
To be a competitive candidate, you should have:
For a competitive advantage, it would be beneficial if you also possess previous record of successfully impacting regulatory strategies for IVD and/or software as medical device and good understanding of related digital health development (e.g., radio regulations, cyber security, SaMD).
On a personal level, you have a strong interest in developing people and teams with a proven track record of strong results. you bring excellent communication skills and are recognized as a leader who excels in driving change and innovation. Your ability to inspire those around you to exceed their best is notable, and your ambition is evident as you strive to advance as a future leader beyond this position. Additionally, you bring experience in effectively managing key stakeholders.
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 and 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.
About the Department
RA Digital Health & IVD is responsible for enabling personalization of patient treatments by providing products that build on the Novo Nordisk 5D strategy of integrating Drugs, Device, Digital, Diagnostics and Data into personalised treatment pathways. Furthermore, we liaise with relevant authorities and in close connection with Novo Nordisk specialist teams and external partners. We are involved through all phases of product development and roll-outs. Above all, we provide regulatory expertise in terms of SaMD, Connected Medical Devices and Companion Diagnostics.
RA Digital Health & IVD is part of Global Regulatory Affairs (GRA). GRA is accountable for regulatory licenses for current and future products responsive to the worldwide business needs of Novo Nordisk. Our HQ functions are located in Copenhagen, Denmark and Bangalore, India, Gatwick, UK and Boston, US.