Paula Antunes

Global Regulatory Lead, GRA - RA Digital Health & IVD at Novo Nordisk

Speaker

I'm Paula, an engineer passionate about innovation, regulatory affairs, and improving people’s lives.

Over 10 years, I've been part of various MedTech companies in Denmark, from start-ups to major enterprises. Proficient in medical devices, IVD, and digital health, I've generated and implemented regulatory strategies for global markets including EU, China, US, Japan, and Brazil.

My expertise in connected devices has given me a good understanding of the specific challenges that these technologies face, specially regarding cybersecurity and interoperability.

Presently, as a Global Regulatory Lead at Novo Nordisk, I work with my team of regulatory professionals to launch digital health products worldwide and I advocate for cybersecurity within external industry forums representing my company's position. I have a Master's degree in Biomedical Engineering.