Medical device company located in Caesarea is looking for a RA specialist to Support the different regulatory activitys:
- Regulatory assessments and registrations worldwide
- Review promotional material and labeling for regulatory compliance.
- Write, update and maintain technical files for Class I and Class IIa.
- Support global regulatory requirements and submissions.
- Regulatory assessment of changes.
- A degree in a related scientific or engineering discipline
- Minimum of 5 years of related experience in regulatory affairs (Medical device or pharmaceutical industry)
- Fluent in Hebrew and English (verbal and written communication skills)
Nice to Have
Experience in the medical device industry- Significient Advantage
Advanced degree in a related scientific or engineering discipline
Knowledge of medical device regulations and standards, especially US (FDA) and EU (MDD/MDR) related