Regulatory Affairs Specialist - Consultant (Medical Devices)
KI-Beschreibung
In this role, you will navigate the complexities of medical device regulations, ensuring compliance while managing documentation and responding to health authority inquiries. Your expertise will facilitate market registrations and address regulatory challenges.
Anforderungen
2 Jahre- •Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related discipline
- •2+ years of experience in Regulatory Affairs within the medical device industry
- •Solid understanding of international medical device regulations (EU MDR, ISO 13485, FDA requirements)