Senior Regulatory Professional
Novo Nordisk A/S
London, United Kingdom
4d ago

Do you have experience working with regulated digital health solutions and medical devices? Do you want to work with regulation of innovative digital health solutions and devices?

Are you able to take the lead and drive regulatory strategies for high impact projects? Then you might be our new Senior Regulatory Affairs professional (RA) Digital Health Products.

The position

As Senior RA professional, you will be fully integrated with our Digital Health project teams from the start. You’ll be working closely with a wide range of stakeholders from Digital Health-IT, Device R&D, Commercial, Medical & Science, as well as regulatory affairs colleagues and external affiliates.

You’ll also contribute to ground-breaking digital health projects on a daily basis expanding your regulatory expertise and building a global network at the same time.

You will get flexible working conditions (remote / hybrid), this position can either be connected to our headquarters in Søborg, Denmark or for candidates currently based in the UK, in our offices in Gatwick, UK.

Your main responsibilities will be :

  • Develop and implement medical devices regulatory strategies based on current legislation.
  • Maintain dialogue and negotiate with relevant authorities.
  • Ensure minimum time to market.
  • Submit regulatory files for product approval.
  • Qualifications

  • MSc and / or Ph.D in Biochemistry, Pharmaceutical Sciences, Engineering, IT or similar discipline / degree.
  • Experience in Digital Health products or Medical Devices either from the pharmaceutical industry, medical device industry or from a medical agency is needed.
  • A scientific and technical mindset and an understanding of related Digital health development (e.g., radio regulations, cyber security, SaMD).
  • Ability to communicate complex topics scientifically and professionally.
  • Fluent in written and spoken English, have strong communication skills and a positive attitude.
  • On a personal level, you are self-motivated and have a strategic mind-set. You bring a proactive and innovative approach to provide valuable input and support setting the strategic direction for your projects.

    Finally, you can communicate complex topics to many different stakeholders from R&D to production and commercial.

    About the department

    Novo Nordisk is very ambitious when it comes to the development of digital solutions and devices. Our inspiring purpose is to let people optimize and personalize their use of our products, helping them benefit even more from our insulins and other treatments.

    Moreover, Novo Nordisk Digital Health solutions are developed with compliance in mind. Liaising between relevant authorities and Novo Nordisk specialist teams, you’ll be involved through all phases of product development and roll-out.

    RA professionals come from many academic and professional backgrounds, bringing valuable insights and expertise to the team and the company to ensure minimum time to market.

    This makes RA a truly multi-disciplinary department with high professional standards and excellent opportunities for fast-paced professional development and career progression.

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