Head of Regulatory Affairs Digital Health and IVD
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Søborg
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? With this unique opportunity, you will be leading the Global Regulatory Affairs Digital Health and IVD unit and deliver best-in-class regulatory strategies and support the organisation to optimise our assets. So, if you have vast experience with digital health and want to impact an already strong and well-performing area, then look no further. Apply now! The position As Head of RA Digital Health & IVD, you will be responsible driving the development and execution of the global regulatory strategies for the Digital Health and IVD activities. You will lead a team of approximately 16 employees located in Søborg, Denmark, Gatwick, UK and Bangalore, India. You will be part of the Global Regulatory Affairs (GRA) Leadership team and report directly to the GRA CVP. Your responsibilities will include: Setting direction, supervising and develop the team with best-in-class RA competencies. Building a visible platform from which to strengthen the unit, ensuring Digital Health and IVD plays a key part in regulatory strategies across the Novo Nordisk portfolio. Ensuring implementation of high regulatory science standards. Role-model change. Driving our culture of collaboration and patient-centric ambition. The position is global, so you can either work out from our hub in Søborg, Denmark, Bangalore, India or from our office in Gatwick, London, UK. Travel will be required. Qualifications To excel in this role, we anticipate that you bring: Master of Science (MSc) or Doctor of Philosophy (PhD) in a scientific, engineering or other relevant field. A significant experience within Regulatory Affairs (directly or indirectly) with +10 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. 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. Good understanding of related digital health development ( e.g., radio regulations, cyber security, SaMD ). S cientific and technical mindset with familiarity of working in agile and waterfall software development processes. On a personal level, 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, including senior Research & Development management, production, commercial, and affiliates. 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 IVD & DH 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.
Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact Should you wish to learn more about this unique position, please feel welcome to call Michael Søberg Christensen at +45 3075 4608. Deadline 07 December 2023. We kindly suggest that you do not attach a photo of yourself to your application or resume, as it helps us be more fair in our selection process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact Should you wish to learn more about this unique position, please feel welcome to call Michael Søberg Christensen at +45 3075 4608. Deadline 07 December 2023. We kindly suggest that you do not attach a photo of yourself to your application or resume, as it helps us be more fair in our selection process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 22.11.2023, 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.
- Apoteker
- Søborg
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