Daniela LealGlobal Regulatory Affairs Lead MDR/IVDR at Zimmer Biomet
- Daniela has been the Global Regulatory Affairs Lead for EU MDR at Zimmer Biomet for over 2 years, where she sets the interpretation and operational strategy to implement the new/updated requirements of the new Regulation across 24 legal Manufacturers within the network. Daniela is a MsC in Biomedical Engineering from University of Minho (Braga, Portugal), and has been supporting several medical devices companies, from small start-ups to big corporations like Johnson & Johnson and Zimmer Biomet, in both Quality and Regulatory Affairs areas. Her near decade of experience includes also varied types of devices (EU) class I to III (active/non-active; implantable/non-implantable), as well as IVDs. Daniela has also been engaged in medical technology industry groups, like MedTech Europe, supporting to voice the Industry interpretation and concerns on the EU MDR implementation to the rest of the stakeholders (i.e. Competent Authorities, Notified bodies, and the EU Commission).