- Led Regulatory Affairs activities for medical devices ensuring compliance with European regulations (EU MDR – Regulation (EU) 2017/745).
- Acted as an expert in medical device classification with a focus on Class IIa and IIb ensuring correct application of classification rules.
- Cordinated preparation review and maintenance of technical documentation (EU MDR Annexes II and III).
Regulatory Affairs Specialist - Boituva - beBeeRegulatoryAffairs
beBeeRegulatoryAffairs Boituva
há 2 semanas
Título do emprego: Regulatory Affairs Specialist
Descrição
Regulatory Affairs Specialist
About the Role: